FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES
K Number: K952591
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
5
Review Days
67
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Basic Information
- Device Name
- ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES
- K Number
- K952591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
- Date Received
- June 5, 1995
- Decision Date
- August 11, 1995
- 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 Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952588 | ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES | Oct 12, 1995 | Substantially Equivalent |
| K952590 | ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES | Aug 14, 1995 | Substantially Equivalent |
| K926132 | ROYAL SHIELD SHIELD GLOVES | Dec 22, 1993 | Substantially Equivalent |
| K890907 | ROYAL SHIELD LATEX EXAMINATION GLOVES(TM) | Apr 26, 1989 | Substantially Equivalent |