ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O
FDA 510(k) clearance K991743 · decided 1999-06-23
Clearance details
- K-number
- K991743
- Device name
- ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O
- Applicant
- Shield Gloves Manufacturer (M) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 1999-05-21
- Decision date
- 1999-06-23
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chem recall (Z-2308-2016) | Beckman Coulter Inc. | 2016-08-01 |