Disposable Surgical Face Mask (FM-34EE,FM-44EE)— 510(k) K220597

Clearance details

Applicant

Qingdao Bestex Rubber & Plastic Products Co., Ltd.

Product code

Code FXX

Device class

Class 2

Regulation

21 CFR 878.4040

Advisory panel

General, Plastic Surgery

Date received

2022-03-01

Decision date

2022-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Qingdao, CN

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• K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)2026-02-19
• K252830 — Disposable Surgical Face Mask (3P00B, C2900)2026-01-12
• K252650 — Disposable Medical Face Mask2026-01-05

• K042645 — POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING2004-11-26
• K031157 — POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED2003-08-15
• K022566 — POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO2002-10-15
• K012709 — POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)2001-10-01
• K002087 — BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)2000-09-13

Injury

137

Total

137

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 →