Powder Free Nitrile Examination Glove Black and Dual Color White-Blue— 510(k) K201857

Clearance details

Applicant

Careplus (M) Sdn Bhd

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2020-07-06

Decision date

2021-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Seremban, MY

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• K210656 — ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs2021-06-24
• K202765 — ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs2021-05-27

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 →