510(k) · Cleared

Cleared

Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2

K033564510(k) TraditionalCleared Feb 24, 2004104-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

Kanam Latex Industries Pvt., Ltd. · KGO Surgeon'S Gloves

Cleared on Feb 24, 2004 after a 104-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.

Decided: Feb 24, 2004
Review: 104 days
Class: Class I
Product code: KGO
Recalls: None
Predicates: 0

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

This deviceK033564 Powder Free Latex Surgeons Gloves Polymer Coated Sterile with…Kanam Latex Industries Pvt., Ltd. · 2004
Descendant · cites it directly · 4 of its ownK060030 The Double GloveBiobarrier, Inc. · 2006
Descendant · 2 generations on · 2 of its ownK071465 Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 2007
Descendant · 2 generations on · 1 of its ownK071565 Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007
Descendant · 3 generations on · 0 of its ownK112089 Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011
Descendant · 3 generations on · 0 of its ownK101163 Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA · 2010

Most influential descendants

Showing 5 of 5 · See all

K060030The Double GloveBiobarrier, Inc. · 2006 · cites it directly4descendants
K071465Biogel Orthopaedic Surgical Glove with Non-Pryogenic StatementMolnlycke Health Care Us, LLC · 2007 · 2 generations on2descendants
K071565Biogel Indicator Underglove with Non-Pyrogenic StatementMolnlycke Health Care Us, LLC · 2007 · 2 generations on1descendant
K112089Biogel Orthopor Brown Surgical GloveMolnlycke Health Care Us, LLC · 2011 · 3 generations on0descendants
K101163Biogel Orthopro Indicator UndergloveMolnlycke Health Care USA · 2010 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K033564	Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional…	Kanam Latex Industries Pvt., Ltd.	2004	—
+1	K060030	The Double Glove	Biobarrier, Inc.	2006	—
+2	K071465	Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement	Molnlycke Health Care Us, LLC	2007	—
+2	K071565	Biogel Indicator Underglove with Non-Pyrogenic Statement	Molnlycke Health Care Us, LLC	2007	—
+3	K112089	Biogel Orthopor Brown Surgical Glove	Molnlycke Health Care Us, LLC	2011	—
+3	K101163	Biogel Orthopro Indicator Underglove	Molnlycke Health Care USA	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2010	1	0
2011	1	0

FIG. 1 — Lineage of K033564, 2004–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K060030	The Double Glove	Biobarrier, Inc.	2006	4

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, K060030 (Biobarrier, Inc., 2006) has gone furthest, with 4 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

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?

The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K033564 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033564: Powder Free Latex Surgeons Gloves Polymer Coated Sterile with Optional Labeling Claim of E.P. Less Than 50 UG/DM2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033564

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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