POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)— 510(k) K974183

Clearance details

Applicant

Sri Johani Sdn. Bhd.

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

1997-11-06

Decision date

1997-12-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Selangor, MY

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• K993458 — POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)1999-11-10
• K981039 — POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)1998-04-21
• K980037 — POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)1998-02-09

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 →