Surgeon's Cap
FDA 510(k) K953879 · American Threshold Industries, Inc.
510(k) numberK953879
Submission
- Device name
- Surgeon's Cap
- Applicant
- American Threshold Industries, Inc.
Enka, NC, US - Received
- August 16, 1995
- Decision date
- January 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FYF – Cap, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FYF
| 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 |
| 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 |
More from A Plus International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971483 | Secure-Wrap (TM) Sterilization WrapFRG · Traditional | 06/24/1997SE |
| K953878 | Bouffant CapFYF · Traditional | 01/05/1996SE |
| K952115 | Barrier Gown, Kool-Gard Backless GownFYC · Traditional | 09/25/1995SE |
| K952114 | Kool Gard Singles GownFYC · Traditional | 09/25/1995SE |
| K952116 | Cover GownFYC · Traditional | 09/05/1995SE |
| K934085 | Modification of Surgical Eyeshield MaskHOY · Traditional | 11/12/1993SE |
| K915530 | Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional | 08/17/1992SE |
| K915740 | Disposable O.R. Towel, SterileKKX · Traditional | 06/22/1992SE |
| K912110 | Disposable O.R. TowelKKX · Traditional | 07/25/1991SE |
| K894383 | Disposable Shoe CoverFXP · Traditional | 09/12/1989SE |
Questions and answers
When was Surgeon's Cap cleared by the FDA?
Surgeon's Cap (K953879) received a 510(k) decision of Substantially Equivalent on January 5, 1996, 142 days after the submission was received.
What is the product code of K953879?
The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.