510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993117Substantially Equivalent

Safeskin Pfe-Xtra Powder-Free Latex Examination Gloves, Protein Content 50 Mcg or Less, for Use with Chemotherapeutic Ag

Safeskin Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993117 is the FDA 510(k) clearance record for SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG, a class I device, cleared for Safeskin Corp. on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex 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 24 510(k) clearances for Safeskin Corp., from to . As of , FDA records show no recalls naming K993117.

Clearance record

Decision date
Received
(164 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Safeskin Corp. 12671 High Bluff Dr., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code LYY

Trailing 12 months

FDA records hold no clearances under product code LYY in the trailing twelve months.

FDA records show no clearances under product code LYY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260