510(k) K894516
- Device
- VISOSHIELD(TM), SURGICAL EYE PROTECTOR
- Applicant
- POLAMEDCO, INC.
- 510(k) number
- K894516
- Product code
- FXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-09-12
- Date received
- 1989-07-19
- 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#
- Contact
- JACKIE FARRANT
- Address
- 8295 S.La Cienega Blvd. Inglewood CA US 90301 90301
FDA Registration Numbers#
- 3002813051
- 3008132392
- 3007615588
- 3004111573
- 3026263452
- 3016622475
- 3009488612
- 1929938
- 1058397
- 3003348807
- 1836161
- 1064584
- 1719330
- 3006973666
- 3016615220
- 8030607
- 3015727296
- 2083545
- 3041276890
- 3005599545
- 3018609298
- 3006897516
- 3010598169
- 9614747
- 2110898
- 3017952635
- 3004133236
- 3013503815
- 3003674698
- 1061124
- 3008386507
- 3007942528
- 3013735189
- 3011391433
- 1420054
- 1320894
- 2648727
- 3007479164
- 3021486363
- 1055236
- 1025972
- 3009307523
- 3012314549
- 3012268821
- 3011554160
- 3013006775
- 3013557562
- 3017450342
- 3045855232
- 2424472
- 2437780
- 3005246939
- 3010131137
- 1423537
- 3009104075
- 3002691626
- 3006942307
- 9616872
- 3006540014
- 3027977504
- 9616096
- 3014421917
- 3019848304
- 3011545608
- 8022899
- 1422598
- 3017229009
- 3005327291
- 3008770655
- 3003495693
- 1530671
- 3016948452
- 3016966810
- 3004995451
- 3023228837
- 1921846
- 3011089435
- 3005142514
- 2433012
- 3003230618
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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