Product code FYF
- Device name
- Cap, Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4040
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972227 | SHOE COVER | American Seal Co. | 1997-09-09 |
| K955833 | NIOMED SURGICAL CAPS | Amerasia Corp. | 1996-03-15 |
| K954556 | SURGICAL CAP | Thai Disposable Products Co., Ltd. | 1996-03-12 |
| K954455 | NIOMED BOUFFANT CAPS | Amerasia Corp. | 1996-01-23 |
| K954454 | NIOMED SURGICAL HOOD | Amerasia Corp. | 1996-01-23 |
| K953879 | SURGEON'S CAP | American Threshold Industries, Inc. | 1996-01-05 |
| K953878 | BOUFFANT CAP | American Threshold Industries, Inc. | 1996-01-05 |
| K913700 | DISPOSABLE BOUFFANT CAP | Gem Nonwovews, Inc. | 1991-10-04 |
| K882346 | INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD | Nordbye, Milchman, Barlage | 1988-06-30 |
| K882284 | SURGEONS CAP | A Plus International, Inc. | 1988-06-23 |
| K882283 | BOUFFANT CAP | A Plus International, Inc. | 1988-06-23 |
| K880481 | CARETEX SURGEON'S CAPS | James River Corp. | 1988-02-24 |
| K875261 | KIMBERLY-CLARK FULL COVERAGE HOOD | Kimberly-Clark Corp. | 1988-01-22 |
| K874066 | SURGICAL CAPS | Interpro Intl., Inc. | 1987-11-04 |
| K873830 | TECNOL SURGEON'S CAP | Tecnol New Jersey Wound Care, Inc. | 1987-10-23 |
| K870618 | VARIOUS TYPES OF SURGICAL GARMENTS | Kin Yuh Hung Co., Ltd. | 1987-03-09 |
| K870617 | VARIOUS TYES OF SURGICAL GARMENTS | Greene International Corp. | 1987-03-09 |
| K863359 | BOUFFANT-STYLE SURGICAL CAP | Kimberly-Clark Corp. | 1986-09-29 |
| K851558 | SURGICAL CAP CALOT | Roseburg SA | 1985-04-30 |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Medicon, Inc. | 1985-01-10 |
| K831357 | BOUNDARY HEADWEAR | Procter & Gamble Mfg. Co. | 1983-06-02 |
| K810199 | DISPOSABLE SURGERY CAPS & HOODS | Anago, Inc. | 1981-02-13 |
| K802186 | DISPOSABLE NURSES CAP | Anago, Inc. | 1980-09-26 |
| K800810 | FLARE DIS. NONWOVEN HEAD COVERS | Flare Products, Inc. | 1980-05-20 |
| K800511 | SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP | American Convertors Div., American Pharmaseal | 1980-04-16 |
| K770260 | CAP, CLARION NURSES OR (TECHNIC) | Sherwood Medical Industries | 1977-03-07 |
| K770259 | CAP, CLARION SURGEON'S | Sherwood Medical Industries | 1977-03-07 |
| K770258 | CAP, CLARION NURSES, STYLE BOUFFANT 21 | Sherwood Medical Industries | 1977-03-07 |
| K761071 | P.S.M. JUSTA KAP | The Owenby Co. | 1976-12-30 |
| K761069 | P.S.M. BOTIQUE CAP | The Owenby Co. | 1976-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10097604414033 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2024-08-12 |
| 10097604419014 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2024-08-12 |
| 10097604455029 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2024-08-12 |
| 10097604414019 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2023-08-28 |
| 10097604357521 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2023-08-28 |
| 10097604428726 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2023-08-28 |
| 08056646507771 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507535 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507818 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507795 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507757 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507733 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507719 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507696 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507672 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507658 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507610 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507597 | Omnicap | OMNIA SRL | 2023-06-20 |
| 08056646507559 | Omnicap | OMNIA SRL | 2023-06-20 |
| 10097604467244 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2023-04-10 |
| 10097604419021 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2023-04-10 |
| 10097604412367 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604404034 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604404027 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604404010 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10097604429426 | Tronex International, Inc. | TRONEX INTERNATIONAL, INC. | 2022-10-28 |
| 10080196007134 | Medline | MEDLINE INDUSTRIES, INC. | 2021-09-22 |
| 10080196751969 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-05-20 |
| 10080196751952 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-05-20 |
| 10080196417902 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-05-20 |