The following data is part of a premarket notification filed by Ansell Healthcare Products Llc with the FDA for Gammex Pi Breach Detect Powder Free Surgical Glove.
| Device ID | K171375 |
| 510k Number | K171375 |
| Device Name: | Gammex PI Breach Detect Powder Free Surgical Glove |
| Classification | Surgeon's Gloves |
| Applicant | Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Contact | Robert Mahler |
| Correspondent | Donald J Cronk Ansell Healthcare Products LLC 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-10 |
| Decision Date | 2018-02-06 |
| Summary: | summary |