510(k) K232777
- Device
- FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- 510(k) number
- K232777
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-01
- Date received
- 2023-09-11
- Regulation
- 878.4040
- Classification name
- Mask, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Caitlin Senter
- Address
- 9120 Lockwood Blvd. Mechanicsville VA US 23116 23116
FDA Registration Numbers
- 3016864576
- 2110898
- 3016884033
- 3012314549
- 3007053183
- 3017180923
- 3021286079
- 3029802606
- 3004105221
- 3015140351
- 3003610374
- 3007048057
- 1051614
- 3021374000
- 9614306
- 3017952635
- 1423537
- 2437780
- 3015633688
- 8030678
- 3012711490
- 3036622014
- 3005030944
- 3021450335
- 3007305485
- 3011434305
- 3008048818
- 3014926389
- 3012268821
- 3003230618
- 3005083505
- 3007966889
- 3009488612
- 3004962765
- 3004361903
- 3010363542
- 3016096096
- 3042272797
- 3008386507
- 3009526454
- 9615909
- 3008808082
- 9680284
- 3023917
- 3012761602
- 3005327291
- 3008384335
- 3005558160
- 3014146451
- 3014142845
- 3002661124
- 3021486363
- 3016426851
- 3016761372
- 3008311433
- 3012104670
- 3014683120
- 3038718579
- 3011554160
- 3017598017
- 3017910185
- 3016654890
- 3030419987
- 3016426842
- 3007134734
- 3042366009
- 3011391433
- 1720499
- 3030582179
- 8022899
- 3015967359
- 3016649599
- 3007046497
- 9680222
- 3007942528
- 3030172764
- 3016601021
- 9616862
- 3010598169
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |