510(k) clearance
Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink
- 510(k) number
- K262208
- Applicant
- Yty Industry (Manjung) Sdn Bhd
- Decision date
- Oct 1, 2026
- Date received
- Jun 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LZA
- Device type
- Polymer Patient Examination Glove
- Device class
- Class I
- Regulation
- 21 CFR 880.6250
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Sitiawan, MY