510(k) · Cleared

Cleared

Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves

K063757510(k) TraditionalCleared Jul 27, 2007220-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

Shanghai Motex Healthcare Co., Ltd. · KGO Surgeon'S Gloves

Cleared on Jul 27, 2007 as substantially equivalent to K050071 (H.B.M. USA Co.,Inc., 2005) after a 220-day review. Its family tree reaches back 1 generation to 2005. 17 later devices descend from it.

Decided: Jul 27, 2007
Review: 220 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K050071 (2005). 17 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK050071 Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005
This deviceK063757 Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical GlovesShanghai Motex Healthcare Co., Ltd. · 2007
Descendant · cites it directly · 14 of its ownK130301 Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013
Descendant · 2 generations on · 12 of its ownK151114 Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex…St. Marys Rubbers Pvt, Ltd. · 2015
Descendant · 3 generations on · 11 of its ownK172942 Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with…Beta Healthcare Products Pvt., Ltd. · 2018
Descendant · 4 generations on · 8 of its ownK192328 JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
Descendant · 5 generations on · 2 of its ownK212848 Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 2021

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2012high 5 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 17 · See all

K130301Latex Surgeon's Gloves (Powdered and Powder Free)Elimedical Devices (Fujian), Inc. · 2013 · cites it directly14descendants
K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves…St. Marys Rubbers Pvt, Ltd. · 2015 · 2 generations on12descendants
K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content…Beta Healthcare Products Pvt., Ltd. · 2018 · 3 generations on11descendants
K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020 · 4 generations on8descendants
K212848Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd · 2021 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050071	Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove	H.B.M. USA Co.,Inc.	2005	—
0 (this device)	K063757	Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves	Shanghai Motex Healthcare Co., Ltd.	2007	—
+1	K130301	Latex Surgeon's Gloves (Powdered and Powder Free)	Elimedical Devices (Fujian), Inc.	2013	—
+2	K151114	Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s…	St. Marys Rubbers Pvt, Ltd.	2015	—
+3	K172942	Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein…	Beta Healthcare Products Pvt., Ltd.	2018	—
+4	K192328	JR.MEDIK Latex Surgeon’s Gloves Powder Free	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	2020	—
+5	K212848	Sterile Latex Surgical Gloves Powder Free	Pentavest Holdings Sdn Bhd	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	3	0
2018	1	0
2019	1	0
2020	1	0
2021	5	0
2022	1	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K063757, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K050071	Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons Glove	H.B.M. USA Co.,Inc.	2005	—

What descends from it? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130301	Latex Surgeon's Gloves (Powdered and Powder Free)	Elimedical Devices (Fujian), Inc.	2013	14
K142992	TULIP Natural Rubber Latex Surgeon's Glove (Powdered)	Shanghai Jinxiang Latex Products Co., Ltd.	2015	0
K113233	Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling Claim	Shen Wei (Usa), Inc.	2012	0

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?

Its one ancestor has no recall.
Of its descendants, K130301 (Elimedical Devices (Fujian), Inc., 2013) has gone furthest, with 14 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. 2007, this device’s year, is highlighted.

FDA decisions per year · KGO

1in 2025

2007high 15 (2020) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGO

185in 2023

2007high 257 (2014) · low 48 (2009)2026

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

Recalls per year · KGO

2in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	10	113	0	13
2008	2	—	0	8
2009	3	48	15	14
2010	6	87	1	16
2011	11	90	0	14
2012	7	133	0	14
2013	6	184	0	41
2014	7	257	0	28
2015	12	225	0	11
2016	9	218	2	15
2017	12	111	1	20
2018	7	194	8	15
2019	11	204	0	51
2020	15	117	0	15
2021	14	199	0	14
2022	6	127	2	10
2023	14	185	2	28
2024	2	—	0	18
2025	1	—	0	21
2026	2	—	0	—

What is it indicated for?

Motex Powder-Free Surgical 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.

Motex Powdered Latex Surgical 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063757: Motex Powder-Free Surgical Gloves and Lightly Powdered Surgical Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063757

Report an extraction error

Are you the manufacturer?

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