Guthrie Powder-Free Latex Surgical Glove with (50 Micrograms or Less)
K001049 is the FDA 510(k) clearance record for GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS), a class I device, cleared for Guthrie Medicare Products (Melaka) Sdn Bhd on under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 12 510(k) clearances for Guthrie Medicare Products (Melaka) Sdn Bhd, from to . As of , FDA records show no recalls naming K001049.
Clearance record
- Decision date
- Received
- (53 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- Guthrie Medicare Products (Melaka) Sdn Bhd 55 Northern Blvd., Suite 200, Great Neck NY
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code KGO
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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