Gauze and Lap Sponges -Sterile & Non-Sterile
FDA 510(k) K881395 · A Plus International, Inc.
510(k) numberK881395
Submission
- Device name
- Gauze and Lap Sponges -Sterile & Non-Sterile
- Applicant
- A Plus International, Inc.
La Puente, CA, US - Received
- April 4, 1988
- Decision date
- April 28, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EFQ – Gauze/Sponge, Internal
- Device class
- Unclassified
Other 510(k)s with product code EFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991757 | Non-Absorbable Gauze for External Use, Sterile and Non SterileEFQ · Traditional | Furlong Industries | 08/12/1999SE |
| K991215 | Symtex Gauze Pads (1'S) and Symtex Gauze Sponges Sterile 2'S and Sterile 10'SEFQ · Traditional | Symtex Healthcare Corp. | 06/11/1999SE |
| K990974 | Vitop DressingEFQ · Traditional | Wonder & Bioenergy Hi-Tech America, Inc. | 06/09/1999SE |
| K990584 | Gauze Sponges: Laparotomy Sponge, X-Ray DetectableEFQ · Traditional | Broadline Medical Industries | 04/23/1999SE |
| K984187 | Crosstex Non-Woven SpongesEFQ · Traditional | Crosstex Intl. | 02/18/1999SE |
| K983016 | Gauze, Sponges, Cat # 11-003EFQ · Traditional | Vitalcare Group, Inc. | 02/12/1999SE |
| K983348 | Dynarex Tracheostomy SpongeEFQ · Traditional | Dynarex Corp. | 12/11/1998SE |
| K983450 | Starryshine Gauze SpongeEFQ · Traditional | T.C. Dental Products, Inc. | 11/12/1998SE |
| K982648 | Joan IIEFQ · Traditional | Celanese Acetate Co. | 09/30/1998SE |
| K980791 | Dumex Pak-Its Woven Ribbon PackingEFQ · Traditional | Dumex Medical Surgical Products, Ltd. | 04/29/1998SE |
More from Dumex Medical Surgical Products, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K213001 | Procedure Mask, Surgical MaskFXX · Traditional | 05/11/2022SE |
| K102861 | Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with Pe Laminated…KKX · Traditional | 01/13/2011SE |
| K093169 | Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown…FYA · Traditional | 11/12/2009SE |
| K031353 | Solution Face MasksFXX · Traditional | 06/19/2003SE |
| K882284 | Surgeons CapFYF · Traditional | 06/23/1988SE |
| K882283 | Bouffant CapFYF · Traditional | 06/23/1988SE |
| K882282 | Suit, SurgicalFXO · Traditional | 06/23/1988SE |
| K882281 | Gown, Isolation, Surgical (Fyc)FYC · Traditional | 06/23/1988SE |
| K882280 | Cover, Shoe Operating RoomFXP · Traditional | 06/23/1988SE |
| K881396 | Operating Room Towels -Sterile & Non-SterileKKX · Traditional | 04/29/1988SE |
Questions and answers
When was Gauze and Lap Sponges -Sterile & Non-Sterile cleared by the FDA?
Gauze and Lap Sponges -Sterile & Non-Sterile (K881395) received a 510(k) decision of Substantially Equivalent on April 28, 1988, 24 days after the submission was received.
What is the product code of K881395?
The FDA product code is EFQ – Gauze/Sponge, Internal, a Unclassified device.