BAY MEDICAL

FDA Device Registration & Listing · Brisbane, CA, US · Registration 3015128453

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015128453
FEI Number
3015128453
Entity Name
BAY MEDICAL
City/State/Country
Brisbane, CA, US
Establishment Address
460 Valley Drive, Brisbane, CA 94005, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Bay Medical (Owner Number: 10058737)
Owner / Operator Contact Address
460 Valley Drive, Brisbane, CA 94005, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K193581
PMA Number
N/A

All Registered Proprietary Names

GripProtect® Precise Nitrile Exam Gloves GripProtect® BLACK 6 Nitrile exam gloves GripProtect® Ultra 8 mil Latex exam gloves GripProtect® Precise BLACK Nitrile exam gloves GripProtect® Precise BLACK Nitrile exam gloves - 50 Count GripProtect® Precise BLACK 5 Nitrile exam gloves

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-15
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-10-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-04
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-10-04
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-04
LYY Latex Patient Examination Glove General Hospital Class 1 880.6250 2020-05-18
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-10-15
QDO Fentanyl And Other Opioid Protection Glove General Hospital Class 1 880.6250 2024-10-15
LZA Polymer Patient Examination Glove General Hospital Class 1 880.6250 2024-10-15

Official Correspondent

David Dorris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bay Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212801 Hong Seng Gloves Sdn Bhd Powder free nitrile examination glove- black, non sterile 2022-01-09
K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves 2026-06-03
K011593 Ansell Healthcare Products, Inc. MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE 2001-06-21
K981039 Sri Johani Sdn. Bhd. POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) 1998-04-21
K101595 Better Care Plastic Technology Cp., Ltd. POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE 2010-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015128453. Last updated year: 2026. Please use registration number 3015128453 when referencing this establishment in official correspondence.
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