510(k) K955513
- Device
- SURGICAL MASK (NON-STERILE)
- Applicant
- UNITED MEDICAL ENT., INC.
- 510(k) number
- K955513
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-22
- Date received
- 1995-12-04
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HERSCHEL PITTS
- Address
- 5003 Wrightsboro Rd. Grovetown GA US 30813 30813
FDA Registration Numbers#
- 3004513970
- 3011547453
- 3008191254
- 3010598169
- 3011050560
- 3015727296
- 3038718579
- 3016714803
- 3011862887
- 3021286079
- 3006540014
- 3011391433
- 3017235663
- 3017450342
- 3016247944
- 3014421917
- 1420054
- 3012354669
- 3045855232
- 3044819802
- 3042366009
- 3026536498
- 3013006775
- 8022890
- 3030067857
- 1055236
- 3016452400
- 3016753714
- 3007307589
- 2431224
- 2433825
- 3010864832
- 3004361903
- 3018514354
- 3002813051
- 1025972
- 9616872
- 9614598
- 3016948452
- 3014683120
- 9616862
- 3007838093
- 3012187973
- 1054241
- 2183301
- 3016654890
- 3007966889
- 3016849443
- 1319639
- 3003610374
- 3008559312
- 3011089435
- 3011707784
- 3009307523
- 3005599545
- 3014925393
- 3011545608
- 3006665149
- 3003230618
- 3018020588
- 3006942545
- 3044026004
- 3017910185
- 3015967359
- 3018116884
- 3016685880
- 1417592
- 3016667418
- 3045816954
- 9615909
- 3005142514
- 1061124
- 2518423
- 3016635391
- 3035744034
- 3005022483
- 3017517827
- 3008770063
- 3010147274
- 3010014065
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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