Data / Medical devices / United States / Bay Medical
Bay Medical: FDA-registered device maker in Brisbane, CA, United States, 6 510(k) clearances
Bay Medical is registered with the FDA (registration 3015128453) in Brisbane, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 6, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015128453
- Address
- 460 Valley Drive, Brisbane, CA, United States, 94005
- Owner or operator
- Bay Medical (10058737)
- Roles
- Specification developer
- First device listed
- May 18, 2020
- Registered through
- 2026
- Brand names listed
- GripProtect® BLACK 6 Nitrile exam gloves, GripProtect® High Risk 14 mil Latex exam gloves, GripProtect® Operon Latex exam gloves, GripProtect® Precise BLACK 5 Nitrile exam gloves, GripProtect® Precise BLACK Nitrile exam gloves, GripProtect® Precise BLACK Nitrile exam gloves - 50 Count, GripProtect® Precise Nitrile Exam Gloves, GripProtect® Ultra 8 mil Latex exam gloves and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| March 20, 2020 | K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| March 11, 2019 | K182241 | Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Co., Ltd. | accessdata.fda.gov |
| February 8, 2007 | K070008 | POWDERED VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Hengde Plastic & Rubber Products Co., Ltd. | accessdata.fda.gov |
| November 30, 1998 | K982877 | MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE | LYY | Substantially Equivalent | Matang Mfg. Sdn. Bhd. | accessdata.fda.gov |
| June 27, 1996 | K953590 | COMFIT | LYY | Substantially Equivalent | Wembley Rubber Products (M) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Polymer Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
Updated April 6, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.