BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)— 510(k) K994281

Clearance details

Applicant

Biopro (M) Sdn Bhd

Product code

Product code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1999-12-20

Decision date

2000-10-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Port Klang, MY

• K253508 — Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile2026-10-29
• K262208 — Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid +2 more2026-10-01
• 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

• K994276 — BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)2000-10-20
• K994043 — CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES2000-01-11
• K992358 — CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)1999-09-10
• K981333 — NITRILON CORRECT-TOUCH1998-06-22

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 →