Laglove Powdered Latex Surgical Gloves with Protein Content Labeling Claim (150 Micrograms or Less)
K992018 is the FDA 510(k) clearance record for LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS), a class I device, cleared for La Glove (M) 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 22 510(k) clearances for La Glove (M) Sdn. Bhd., from to . As of , FDA records show no recalls naming K992018.
Clearance record
- Decision date
- Received
- (44 days to decision)
- Product code
- KGO Surgeon'S Gloves
- Regulation
- 21 CFR 878.4460
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Applicant
- La Glove (M) Sdn. Bhd. Lot 478 Jalan Simpang Balak,, Kajang Selangpr D.E., MY
- 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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