Latex Examination Gloves, Powder Free with Protein Labeling Claim (50 Mcg or Less)
K991686 is the FDA 510(k) clearance record for LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS), a class I device, cleared for Arista Latindo Industrial Ltd. P.T on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list 21 510(k) clearances for Arista Latindo Industrial Ltd. P.T, from to . As of , FDA records show no recalls naming K991686.
Clearance record
- Decision date
- Received
- (25 days to decision)
- Product code
- LYY Latex Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Arista Latindo Industrial Ltd. P.T 128 Jalan Kyai Haji Muhammad, Jakarta Barat, ID
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code LYY
Trailing 12 monthsFDA records hold no clearances under product code LYY in the trailing twelve months.
Show the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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