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FDA PRODUCT CODE · CLASS I

KGOSurgeon'S Gloves

A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear 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.

DEVICE CLASS
Class I
REGULATION
21 CFR 878.4460
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
HO
ImplantLife-sustainingGMP-exemptThird-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K253060Protect Gloves Company Limited · 510k2026-05-22
K250313Harps Europe Manufacturing GmbH · 510k2025-08-19

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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