Cap, Surgical
FDA product code FYF · Class I (low risk) · 21 CFR 878.4040 · General, Plastic Surgery
32510(k) clearances
0PMA approvals
0recalls
Manufacturers
- The Owenby Co. 3
- Sherwood Medical Industries 3
- Amerasia Corp. 3
- Anago, Inc. 2
- American Threshold Industries, Inc. 2
- Kimberly-Clark Corp. 2
- A Plus International, Inc. 2
- American Seal Co. 1
- Surgikos, Inc. 1
- Gem Nonwovews, Inc. 1
- Nordbye, Milchman, Barlage 1
- James River Corp. 1
- Interpro Intl., Inc. 1
- Tecnol New Jersey Wound Care, Inc. 1
- Kin Yuh Hung Co., Ltd. 1
- Greene International Corp. 1
- Roseburg SA 1
- Medicon, Inc. 1
- Procter & Gamble Mfg. Co. 1
- Flare Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972227 | Shoe CoverFYF · Traditional | American Seal Co. | 09/09/1997SE |
| K955833 | Niomed Surgical CapsFYF · Traditional | Amerasia Corp. | 03/15/1996SE |
| K954556 | Surgical CapFYF · Traditional | Thai Disposable Products Co., Ltd. | 03/12/1996SE |
| K954455 | Niomed Bouffant CapsFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K954454 | Niomed Surgical HoodFYF · Traditional | Amerasia Corp. | 01/23/1996SE |
| K953879 | Surgeon's CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K953878 | Bouffant CapFYF · Traditional | American Threshold Industries, Inc. | 01/05/1996SE |
| K913700 | Disposable Bouffant CapFYF · Traditional | Gem Nonwovews, Inc. | 10/04/1991SE |
| K882346 | Instrument Protect-A-Caps, Aka: Tip/Instru. GuardFYF · Traditional | Nordbye, Milchman, Barlage | 06/30/1988SE |
| K882284 | Surgeons CapFYF · Traditional | A Plus International, Inc. | 06/23/1988SE |
| K882283 | Bouffant CapFYF · Traditional | A Plus International, Inc. | 06/23/1988SE |
| K880481 | Caretex Surgeon's CapsFYF · Traditional | James River Corp. | 02/24/1988SE |
| K875261 | Kimberly-Clark Full Coverage HoodFYF · Traditional | Kimberly-Clark Corp. | 01/22/1988SE |
| K874066 | Surgical CapsFYF · Traditional | Interpro Intl., Inc. | 11/04/1987SE |
| K873830 | Tecnol Surgeon's CapFYF · Traditional | Tecnol New Jersey Wound Care, Inc. | 10/23/1987SE |
| K870618 | Various Types of Surgical GarmentsFYF · Traditional | Kin Yuh Hung Co., Ltd. | 03/09/1987SE |
| K870617 | Various Tyes of Surgical GarmentsFYF · Traditional | Greene International Corp. | 03/09/1987SE |
| K863359 | Bouffant-Style Surgical CapFYF · Traditional | Kimberly-Clark Corp. | 09/29/1986SE |
| K851558 | Surgical Cap CalotFYF · Traditional | Roseburg SA | 04/30/1985SE |
| K844704 | Caps (O.R. Nurse, Surgical)FYF · Traditional | Medicon, Inc. | 01/10/1985SE |
| K831357 | Boundary HeadwearFYF · Traditional | Procter & Gamble Mfg. Co. | 06/02/1983SE |
| K810199 | Disposable Surgery Caps & HoodsFYF · Traditional | Anago, Inc. | 02/13/1981SE |
| K802186 | Disposable Nurses CapFYF · Traditional | Anago, Inc. | 09/26/1980SE |
| K800810 | Flare Dis. Nonwoven Head CoversFYF · Traditional | Flare Products, Inc. | 05/20/1980SE |
| K800511 | Shield Lucky Cap; Blossom Bouffant CapFYF · Traditional | American Convertors Div., American Pharmaseal | 04/16/1980SE |
| K770260 | Cap, Clarion Nurses or (Technic)FYF · Traditional | Sherwood Medical Industries | 03/07/1977SE |
| K770259 | Cap, Clarion Surgeon'sFYF · Traditional | Sherwood Medical Industries | 03/07/1977SE |
| K770258 | Cap, Clarion Nurses, Style Bouffant 21FYF · Traditional | Sherwood Medical Industries | 03/07/1977SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | The Owenby Co. | 12/30/1976SE |
| K761069 | P.S.M. Botique CapFYF · Traditional | The Owenby Co. | 12/30/1976SE |
| K761068 | P.S.M. Bouffant CapFYF · Traditional | The Owenby Co. | 12/30/1976SE |
| K760861 | Surgical Corp.FYF · Traditional | Surgikos, Inc. | 11/03/1976SE |