POWDER-FREE VINYL PATIENT EXAMINATION GLOVES— 510(k) K964964
Substantially EquivalentSunmax Enterprise Shanghai Co. , Ltd.
FDA 510(k) clearance K964964 for POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, Substantially Equivalent on 1997-02-07. Applicant: Sunmax Enterprise Shanghai Co. , Ltd.. Device class: 1.
Clearance details
- Applicant
- Sunmax Enterprise Shanghai Co. , Ltd.
- Product code
- Code LYZ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck,, NY, US
Recent devices under product code LYZ
view allMore clearances from Sunmax Enterprise Shanghai Co. , Ltd.
view all- K090336 — SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
- K011765 — SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
- K011717 — SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
- K960746 — SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.