Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves
K211209 is the FDA 510(k) clearance record for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves, a class I device, cleared for Hycare International Co., Ltd. on under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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...". FDA records list one 510(k) clearance for Hycare International Co., Ltd. As of , FDA records show no recalls naming K211209.
Clearance record
- Decision date
- Received
- (238 days to decision)
- Product code
- LZA Polymer Patient Examination Glove
- Regulation
- 21 CFR 880.6250
- Device class
- Class I
- Review panel
- General Hospital
- Applicant
- Hycare International Co., Ltd. 1197 Moo 3, Asia Hwy., Khuanlang Hatyai, TH
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code LZA
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 2 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 5 |
| July 2026 | 2 |
| August 2026 | 1 |
| September 2026 | 4 |
| October 2026 | 1 |
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