Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K162381Substantially Equivalent

HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs

Healthy Glove Co., Ltd., Hat Yai, TH / Traditional, Substantially Equivalent

K162381 is the FDA 510(k) clearance record for HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, a class I device, cleared for Healthy Glove Co., Ltd. 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 2 510(k) clearances for Healthy Glove Co., Ltd., from to . As of , FDA records show no recalls naming K162381.

Clearance record

Decision date
Received
(160 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Healthy Glove Co., Ltd. 119 Kanchanavanich Rd., Tambol Patong, Hat Yai, TH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZA

Trailing 12 months
16 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 20261