510(k) K210302
- Device
- Disposable Medical Mask
- Applicant
- Anhui JBH Medical Apparatus Co., Ltd.
- 510(k) number
- K210302
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-05-14
- Date received
- 2021-02-03
- Regulation
- 878.4040
- Classification name
- Mask, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dandan Yang
- Address
- # 116 Qicang Rd., Mingguang City Chuzhou CN 239400 239400
FDA Registration Numbers#
- 3007134734
- 3026263452
- 1530671
- 3007307589
- 3016849443
- 3005022483
- 3044688593
- 3009488612
- 3011547453
- 3016096096
- 3017425988
- 3013557562
- 9710583
- 3004962765
- 3016680721
- 3021286079
- 3005327291
- 3007392007
- 3009104075
- 3017517827
- 3004491689
- 1064584
- 3012628066
- 2437780
- 3016667418
- 9616862
- 3016649599
- 3016622475
- 3016615220
- 3017450342
- 3008384335
- 3036622014
- 3041276890
- 3006973666
- 2424472
- 3013298431
- 3007479164
- 3016601021
- 9680357
- 3018382937
- 3006942307
- 9681151
- 3005030944
- 3010409218
- 3015136704
- 9615909
- 2029234
- 9612018
- 2433825
- 3006723155
- 3026536498
- 3007053183
- 8022899
- 3008559312
- 3004753358
- 3016710511
- 1319130
- 3013428737
- 3015058854
- 3044026004
- 3010014065
- 3008107579
- 3016247944
- 1836161
- 3008912871
- 3010155681
- 3016948452
- 3017168988
- 3007407626
- 3016452400
- 3006113314
- 2024980
- 3005558160
- 3030172764
- 3010154727
- 3016714803
- 3016426851
- 3006691703
- 3014819517
- 3006582165
Source Documents#
Other 510(k) Records For Product Code FXX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251967 | HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor | O&M Halyard, Inc. | 2026-03-18 |
| K252534 | Surgical Face Mask (Ear mount) | Zhejiang Hangkang Medical Equipment Co., Ltd. | 2026-03-03 |
| K253398 | Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. | 2026-02-19 |
| K252830 | Disposable Surgical Face Mask (3P00B, C2900) | Beatles Medical Supplies (Xiantao) Co., Ltd. | 2026-01-12 |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 2026-01-05 |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 2025-12-22 |
| K252941 | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops | O&M Halyard, Inc. | 2025-12-11 |
| K252964 | PRIMED Surgical and Procedure Masks | Primed Medical Products, Inc. | 2025-11-04 |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries, Inc. | 2025-09-17 |
| K250082 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | 2025-06-18 |
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce | Owens & Minor (O&M) Halyard, Inc. | 2025-05-30 |
| K242502 | Aurelia Surgical Mask ASTM Level-3 (2130) | Supermax Healthcare Canada – Supermax Medical | 2024-11-12 |
| K240916 | Surgical Face Mask (Tie on/ Ear loops) | Xiantao Daoqi Plastic Co., Ltd. | 2024-10-18 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | Primed Medical Products, Inc. | 2024-08-26 |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases