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FDA PRODUCT CODE · CLASS I

LYZ — Vinyl Patient Examination Glove

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K260860Basic Medical Technology, Inc. · 510k2026-04-07
K252467Viet Phu Trade and Import Export Co., Ltd. · 510k2025-10-27
K252505Basic Medical Technology, Inc. · 510k2025-08-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA 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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