Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested For Use With The Opioids Fentanyl Citrate, Heroin, And Both Opioids In Simulated Gastric Acid (Vomit)
Summit Glove, Inc
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1530882 | 3001732439 | SUMMIT GLOVE, INC. | 1 | Y | 2026-01-01 | 310 S Grant Blvd MINERVA OH US 44657 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850018374101 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size Small" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374125 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size Medium" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374149 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size Large" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374163 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size X-Large" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374187 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size 2X-Large" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374200 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Green, Size Small" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374224 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Green, Size Medium" | +1(330)868-0066 | klynn@summitglove.com |
| 00850018374248 | AmbiNitrile - "11.5mil, 13"" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Green, Size Large" | +1(330)868-0066 | klynn@summitglove.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 54980 | 1932654561 | K990878 | BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) | LZA | 1999-05-21 |
| 54980 | 2055907000 | K133193 | RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | 2014-06-23 |
| 54980 | 1558858204 | K093517 | NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE | LZA | 2010-06-29 |
| 54980 | 1116662078 | K093516 | NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES | LZA | 2010-06-29 |
| 54980 | 1636222999 | K060402 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) | LZA | 2006-06-09 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LZA | 5 | 2014-06-23 |
Summit Glove, Inc
Summit Glove, Inc
Summit Glove, Inc
SUMMIT GLOVE, INC.
SUMMIT GLOVE, INC.
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