FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
K Number: K990299
·
Decision Mar 29, 1999
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
12
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES
- K Number
- K990299
- 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
- February 1, 1999
- Decision Date
- March 29, 1999
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZA), ordered by most recent decision date.
Powder Free Nitrile Examination Gloves Non-Sterile Black
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Disposable Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General Hospital
Syntex Exam Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
FDA Class 1
·General Hospital
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 |
| K030148 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR | Feb 19, 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 |
| K990117 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE | Feb 19, 1999 | Substantially Equivalent |