510(k) K991743 ยท LYY Latex Patient Examination Glove
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, Crofton MD, US |
| Decision | Substantially Equivalent, Jun 23, 1999 |
| Received | May 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2016 | Beckman Coulter Inc. AU480 Chemistry Analyzers, Reference No. B28624
The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appro Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.