LYY
- Product code
- LYY
- Device name
- Latex Patient Examination Glove
- Device class
- Class 1
- 21 CFR
- 21 CFR 880.6250
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1954 (all years; only the last 3 years are listed here)
FDA classification definition
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 potentially infectious materials and other contaminants.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250069 | 2025-04-29 | Comfort Rubber Gloves Industries Sdn. … | Powder Free Natural Rubber Latex Examination Gloves … | |
| K240266 | 2024-09-09 | Sri Trang Gloves (Thailand) Public Com… | Latex Examination Glove Powder Free (Ocean Blue and … | — |
Official FDA classification page: LYY
Classification and pathway per current FDA publications. Data from openFDA (CC0).