510(k) K823078
- Device
- SPUNGUARD FACE MASK
- Applicant
- KIMBERLY-CLARK CORP.
- 510(k) number
- K823078
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-07
- Date received
- 1982-10-19
- Regulation
- 878.4040
- Classification name
- Mask, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010598169
- 3009104075
- 3010131137
- 1319639
- 3007053183
- 3013503815
- 3014819517
- 8022899
- 3013575574
- 3013006775
- 3006798117
- 3006400329
- 3014312726
- 3008489813
- 1000110779
- 3015060216
- 3011862887
- 3016654890
- 3017194442
- 3010409218
- 3003348807
- 8030607
- 3005327291
- 3044026004
- 3004105221
- 3011707784
- 3004361903
- 3004513970
- 3016753714
- 3007392007
- 3029802606
- 9616096
- 3005090771
- 3006540014
- 3010147274
- 2024980
- 3009488612
- 3007966889
- 9614747
- 3003230618
- 3045062172
- 3016635391
- 3016680688
- 3006942545
- 3011689956
- 3008107579
- 9680222
- 2431224
- 2183416
- 3004995451
- 3017168988
- 3014198412
- 3011434305
- 3018514354
- 3007305485
- 3016096058
- 3016765490
- 3038356900
- 1320894
- 3008240985
- 3012421607
- 2022409
- 3017498782
- 3008850249
- 3038219378
- 3042367543
- 3006942307
- 3016714803
- 3008386507
- 3006897516
- 3012628066
- 3017180923
- 3016948452
- 1921846
- 3031582449
- 3004425647
- 1422598
- 3005246939
- 3008559312
- 3027977504
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#
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