FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
K Number: K030148
·
Decision Feb 19, 2003
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
12
Review Days
35
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Basic Information
- Device Name
- DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
- K Number
- K030148
- 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 Palomar Mountain Industries, Inc.
- Date Received
- January 15, 2003
- Decision Date
- February 19, 2003
- 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 Palomar Mountain Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031142 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Mar 17, 2004 | Substantially Equivalent |
| K031072 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E | May 6, 2003 | Substantially Equivalent |
| K030094 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR | Apr 1, 2003 | Substantially Equivalent |
| K023560 | ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED | Dec 17, 2002 | Substantially Equivalent |
| K023343 | ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED | Oct 28, 2002 | Substantially Equivalent |
| K992100 | PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED | Jul 29, 1999 | Substantially Equivalent |
| K991457 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE | Jul 1, 1999 | Substantially Equivalent |
| K990267 | POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES | Mar 29, 1999 | Substantially Equivalent |
| K990299 | POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES | Mar 29, 1999 | Substantially Equivalent |
| K990117 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE | Feb 19, 1999 | Substantially Equivalent |