FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
K Number: K993454
·
Decision Dec 3, 1999
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
23
Review Days
51
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Basic Information
- Device Name
- POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
- K Number
- K993454
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sri Johani Sdn. Bhd.
- Date Received
- October 13, 1999
- Decision Date
- December 3, 1999
- Product Code
- LYY
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Sri Johani Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K993457 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] | Dec 2, 1999 | Substantially Equivalent |
| K993458 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) | Nov 10, 1999 | Substantially Equivalent |
| K981039 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | Apr 21, 1998 | Substantially Equivalent |
| K980037 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) | Feb 9, 1998 | Substantially Equivalent |
| K980038 | POWDERFREE GREEN LATEX EXAMINATION GLOVES | Feb 9, 1998 | Substantially Equivalent |
| K980039 | POWDERED GREEN LATEX EXAMINATION GLOVES | Feb 9, 1998 | Substantially Equivalent |
| K974886 | POWDERED GREEN NITRILE EXAMINATION GLOVES | Jan 30, 1998 | Substantially Equivalent |
| K974887 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | Jan 29, 1998 | Substantially Equivalent |
| K974183 | POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) | Dec 18, 1997 | Substantially Equivalent |
| K974185 | POLYMER NITRILE EXAMINATION GLOVES | Dec 18, 1997 | Substantially Equivalent |