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FDA PRODUCT CODE · CLASS I

LZAPolymer Patient Examination Glove

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

DEVICE CLASS
Class I
REGULATION
21 CFR 880.6250
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
ImplantLife-sustainingGMP-exemptThird-party review eligible
35
510(K)/PMA CLEARANCES
510k: 35
0
RECALL ENTRIES

Recent clearances

K252117Sw Technologies, Inc. · 510k2026-06-24
K253824Kanglongda Vietnam Protection Technology Company Limited · 510k2026-06-18
K260867Hartalega NGC Sdn. Bhd. · 510k2026-06-17
K260703S&S Glove Corporation · 510k2026-06-03
K260806Vista Industries,, LLC · 510k2026-06-03
K253160Basic Medical Technology, Inc. · 510k2026-01-23
K252549Kossan International Sdn Bhd · 510k2026-01-13
K251141Mercator Medical (Thailand), Ltd. · 510k2025-11-17

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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