Various Tyes of Surgical Garments
FDA 510(k) K870617 · Greene International Corp.
510(k) numberK870617
Submission
- Device name
- Various Tyes of Surgical Garments
- Applicant
- Greene International Corp.
(Formosa) R.O.C., TW - Received
- February 12, 1987
- Decision date
- March 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from A Plus International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883827 | Masks, Various Types of Surgical MasksFXX · Traditional | 11/17/1988SE |
| K883828 | Cone Masks, Various Types of Surgical Cone MasksFXX · Traditional | 10/03/1988SE |
| K880484 | Surgical GarmentsFYC · Traditional | 06/27/1988SE |
| K843075 | Utility Scissors Disposable ItemsJOK · Traditional | 09/05/1984SE |
| K843073 | Fixed Vol. Dispensers, Adjust Vol-HunpipJQW · Traditional | 08/24/1984SE |
| K843074 | Dispos. & Sponge Forceps Pean ArteryGEN · Traditional | 08/17/1984SE |
| K842719 | Standard WheelchairIQC · Traditional | 07/25/1984SE |
Questions and answers
When was Various Tyes of Surgical Garments cleared by the FDA?
Various Tyes of Surgical Garments (K870617) received a 510(k) decision of Substantially Equivalent on March 9, 1987, 25 days after the submission was received.
What is the product code of K870617?
The FDA product code is FYF – Cap, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4040.