PATIENT EXAMINATION GLOVE— 510(k) K961521
Substantially EquivalentShanghai PT Plastics Enterprise Company, Ltd.
FDA 510(k) clearance K961521 for PATIENT EXAMINATION GLOVE, Substantially Equivalent on 1997-01-30. Applicant: Shanghai PT Plastics Enterprise Company, Ltd.. Device class: 1.
Clearance details
- Applicant
- Shanghai PT Plastics Enterprise Company, 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
- Songjiang County Shanghai, CN
Recent devices under product code LYZ
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- K001611 — DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
- K001601 — DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
- K963751 — PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
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