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510(k) K220597

Disposable Surgical Face Mask (FM-34EE,FM-44EE) by Qingdao Bestex Rubber & Plastic Products Co., Ltd. — Product Code FXX

K220597 is an FDA 510(k) premarket notification submitted by Qingdao Bestex Rubber & Plastic Products Co., Ltd. for the device "Disposable Surgical Face Mask (FM-34EE,FM-44EE)". The FDA issued a decision of Substantially Equivalent on May 26, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Qingdao Bestex Rubber & Plastic Products Co., Ltd. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2022
Date Received
Mar 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type
510(k)

Other clearances by Qingdao Bestex Rubber & Plastic Products Co., Ltd.

  • K042645 — POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE… (Nov 26, 2004)
  • K031157 — POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN… (Aug 15, 2003)
  • K022566 — POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E… (Oct 15, 2002)
  • K012709 — POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING… (Oct 1, 2001)
  • K002087 — BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR… (Sep 13, 2000)

Other clearances for product code FXX

  • K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO… (Mar 18, 2026)
  • K252534 — Surgical Face Mask (Ear mount) (Mar 3, 2026)
  • K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (Feb 19, 2026)
  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (Jan 12, 2026)
  • K252650 — Disposable Medical Face Mask (Jan 5, 2026)
  • K243342 — KP Protective Face Mask (Dec 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (Dec 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (Nov 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with… (Sep 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (Jun 18, 2025)

FDA data resources