510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993664Substantially Equivalent

Synthetic Vinyl Medical Examination Powdered Gloves

Top Glove Sdn. Bhd., Klang, Selangor, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993664 is the FDA 510(k) clearance record for SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES, a class I device, cleared for Top Glove Sdn. Bhd. on under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "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...". FDA records list 17 510(k) clearances for Top Glove Sdn. Bhd., from to . As of , FDA records show no recalls naming K993664.

Clearance record

Decision date
Received
(74 days to decision)
Product code
LYZ Vinyl Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Top Glove Sdn. Bhd. Lot 4968, Bt 6, Jalan Teratai, Klang, Selangor, MY
510(k) summary
Statement
Third party review
No

Clearances, product code LYZ

Trailing 12 months
1 clearance under product code LYZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260