Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K222715Substantially Equivalent

Black Nitrile Powder Free Patient Examination Glove, Non Sterile

Safeskin Retailing (Hk) Limited, Hong Kong, CN / Traditional, Substantially Equivalent

K222715 is the FDA 510(k) clearance record for Black Nitrile Powder Free Patient Examination Glove, Non Sterile, a class I device, cleared for Safeskin Retailing (Hk) Limited on under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "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...". FDA records list 4 510(k) clearances for Safeskin Retailing (Hk) Limited, from to . As of , FDA records show no recalls naming K222715.

Clearance record

Decision date
Received
(86 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Safeskin Retailing (Hk) Limited 26th Floor, Beautiful Group Tower, 77 Connaught Rd. Central, Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZA

Trailing 12 months
15 clearances under product code LZA in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code LZA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20265
July 20262
August 20261
September 20264
October 20260