K014134 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G). This device is classified as a Patient Examination Glove (Class I - General Controls, product code FMC).
Submitted by Supergrade Healthcare Products Sdn. Bhd. (Sparks, US). The FDA issued a Cleared decision on January 22, 2002, 36 days after receiving the submission on December 17, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K014134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2001 |
| Decision Date | January 22, 2002 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMC — Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |