# 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, Fe

**Predicate Speed & CAPA Advisory Opportunity Score:** 36/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262208 |
| Device | 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 |
| Applicant | Yty Industry (Manjung) Sdn Bhd |
| Specialty / panel | General Hospital |
| Product code | LZA |
| Device class | 1 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-30 |
| Decision date | 2026-10-01 |
| Review time (days) | 93 |
| Third-party review | No |
| Applicant location | Sitiawan, MY |

## Why this score
- Fast 93-day review: this device is a strong predicate for similar products.
- Posted 35 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262208). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.