OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE— 510(k) K990698

Clearance details

Applicant

Omnigrace (Thailand) , Ltd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1999-03-03

Decision date

1999-05-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hatyai, Songkhla, TH

• K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)2026-09-09
• K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more2026-09-09
• K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more2026-09-08
• K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR2026-08-18
• K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves2026-07-21

• K012402 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM2001-10-12
• K002922 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)2000-10-16
• K993479 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)1999-11-19
• K990696 — OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE1999-05-13
• K990701 — OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE1999-05-05

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →