510(k) Report

510(k) · Cleared

Cleared

Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove

K050071510(k) TraditionalCleared May 11, 2005119-day reviewClass I21 CFR 878.4460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

H.B.M. USA Co.,Inc. · KGO Surgeon'S Gloves

Cleared on May 11, 2005 after a 119-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.

Decided
May 11, 2005
Review
119 days
Class
Class I
Product code
KGO
Recalls
None
Predicates
0

18 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared2015: 3 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2021: 5 descendants cleared2022: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
  2. Descendant · cites it directly · 17 of its ownK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
  3. Descendant · 2 generations on · 14 of its ownK130301 Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013
  4. Descendant · 3 generations on · 12 of its ownK151114 Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex…St. Marys Rubbers Pvt, Ltd. · 2015
  5. Descendant · 4 generations on · 11 of its ownK172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with…Beta Healthcare Products Pvt., Ltd. · 2018
  6. Descendant · 5 generations on · 8 of its ownK192328 JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12013: 12015: 32018: 12019: 12020: 12021: 52022: 12023: 22026: 1
2007high 5 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 18 · See all
  • K063757Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007 · cites it directly17descendants
  • K130301Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013 · 2 generations on14descendants
  • K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves…St. Marys Rubbers Pvt, Ltd. · 2015 · 3 generations on12descendants
  • K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content…Beta Healthcare Products Pvt., Ltd. · 2018 · 4 generations on11descendants
  • K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050071Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc.2005—
+1K063757Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd.2007—
+2K130301Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc.2013—
+3K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s…St. Marys Rubbers Pvt, Ltd.2015—
+4K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein…Beta Healthcare Products Pvt., Ltd.2018—
+5K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201310
201530
201810
201910
202010
202150
202210
202320
202610
FIG. 1 — Lineage of K050071, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KGO device

  1. #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—POWDERED LATEX SURGEON'S GLOVES by CEPHAS MEDICAL
Named without a submission number
—
*—Maxter Sterile Powder Free Surgical Gloves
Named without a submission number
—

What descends from it? (18)

See all 18

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063757Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd.200717

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K063757 (Shanghai Motex Healthcare Co., Ltd., 2007) has gone furthest, with 17 descendants of its own.

How does its category compare?

All KGO devices

KGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGO

1in 2025

2007: 102008: 22009: 32010: 62011: 112012: 72013: 62014: 72015: 122016: 92017: 122018: 72019: 112020: 152021: 142022: 62023: 142024: 22025: 12026 (partial year): 2
2007high 15 (2020) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGO

185in 2023

2007: 113 days median2009: 48 days median2010: 87 days median2011: 90 days median2012: 133 days median2013: 184 days median2014: 257 days median2015: 225 days median2016: 218 days median2017: 111 days median2018: 194 days median2019: 204 days median2020: 117 days median2021: 199 days median2022: 127 days median2023: 185 days median
2007high 257 (2014) · low 48 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGO

2in 2023

2009: 152010: 12016: 22017: 12018: 82022: 22023: 2
2007high 15 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGO

21in 2025

2007: 132008: 82009: 142010: 162011: 142012: 142013: 412014: 282015: 112016: 152017: 202018: 152019: 512020: 152021: 142022: 102023: 282024: 182025: 21
2007high 51 (2019) · low 8 (2008)2025

MAUDE reports naming product code KGO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710113013
20082—08
20093481514
2010687116
20111190014
20127133014
20136184041
20147257028
201512225011
20169218215
201712111120
20187194815
201911204051
202015117015
202114199014
20226127210
202314185228
20242—018
20251—021
20262—0—

What is it indicated for?

MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning,.and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Indications for use as stated in the FDA summary.

Recent decisions in KGO

The KGO category page

  • K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder…Hartalega NGC Sdn. Bhd. · 2026
  • K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company Limited · 2026
  • K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs…Harps Europe Manufacturing GmbH · 2025
  • K240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd. · 2024
  • K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and…Wrp Asia Pacific Sdn. Bhd. · 2024

https://510kreport.com/device/K050071 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050071: Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050071

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026