FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
K Number: K993049
·
Decision Nov 19, 1999
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
14
Review Days
70
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Basic Information
- Device Name
- DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
- K Number
- K993049
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shanghai Antares Industries, Inc.
- Date Received
- September 10, 1999
- Decision Date
- November 19, 1999
- Product Code
- LYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Shanghai Antares Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052612 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR | Nov 22, 2005 | Substantially Equivalent |
| K021853 | DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E | Aug 1, 2002 | Substantially Equivalent |
| K020943 | STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE | Jun 6, 2002 | Substantially Equivalent |
| K012339 | ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW | Oct 16, 2001 | Substantially Equivalent |
| K012499 | ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES | Oct 16, 2001 | Substantially Equivalent |
| K003321 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR | Nov 22, 2000 | Substantially Equivalent |
| K000953 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Apr 20, 2000 | Substantially Equivalent |
| K000872 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Apr 5, 2000 | Substantially Equivalent |
| K992017 | DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE | Aug 5, 1999 | Substantially Equivalent |
| K983531 | POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED | Nov 30, 1998 | Substantially Equivalent |