Data / Medical devices / United States / Mayer Laboratories
Mayer Laboratories: FDA-registered device maker in Berkeley, CA, United States, 21 510(k) clearances and 1 PMA approval
Mayer Laboratories is registered with the FDA (registration 2938651) in Berkeley, CA, United States. It lists 13 device types. The FDA files 21 510(k) clearances and 1 PMA approval under its listings, the newest dated September 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2938651
- Address
- 1400 Shattuck Ave., Suite 9, Berkeley, CA, United States, 94709
- Owner or operator
- MAYER LABORATORIES (2938651)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- November 29, 2001
- Registered through
- 2026
- Brand names listed
- AQUA LUBE, Aqua Lube Natural Patient Lubricant, Aqua Lube Patient Lubricant, Aqua Lube® Natural Gel, Aqua Lube® Natural Personal Lubricant - Regular, Blossom Organics® Natural Moisturizing Lubricant, Blossom Organics® Warm Sensation Lubricant, Callvin and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Condom | HIS | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Condom, Synthetic | MOL | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Sterile | EXJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Intralabial | NUR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Single-Use Internal Condom | MBU | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| September 23, 2021 | K210294 | One Touch Spiral Condom | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Public Company Limited. | accessdata.fda.gov |
| April 15, 2019 | K181844 | One Touch | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Public Company, Ltd. | accessdata.fda.gov |
| March 9, 2015 | K141767 | ID MILLENNIUM, ID MOMENTS SILICONE | NUC | Substantially Equivalent | Westridge Laboratories, Inc. | accessdata.fda.gov |
| August 1, 2013 | K130345 | AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING | NUC | Substantially Equivalent | Mayer Laboratories, Inc. | accessdata.fda.gov |
| March 6, 2012 | K113686 | KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED | HIS | Substantially Equivalent | Mayer Laboratories, Inc. | accessdata.fda.gov |
| December 8, 2011 | K110325 | AQUA LUBE | NUC | Substantially Equivalent | Mayer Laboratories, Inc. | accessdata.fda.gov |
| October 16, 2009 | K081265 | THAI NIPPON MALE LATEX CONDOM | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| November 23, 2004 | K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | HIL | Substantially Equivalent | Rostam , Ltd. | accessdata.fda.gov |
| November 29, 2001 | K013443 | POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 | LYY | Substantially Equivalent | Maxter Glove Manufacturing Sdn Bhd | accessdata.fda.gov |
| October 24, 2001 | K001974 | EZ-ON CONDOM | MOL | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| January 18, 2000 | K994095 | LATEX CONDOM | HIS | Substantially Equivalent | Thai Nippon Rubber Industry Co., Ltd. | accessdata.fda.gov |
| November 17, 1999 | K993134 | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) | LZA | Substantially Equivalent | Seal Polymer Industries Bhd. | accessdata.fda.gov |
| July 7, 1999 | K991849 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC | LYY | Substantially Equivalent | Seal Polymer Industries Bhd. | accessdata.fda.gov |
| May 5, 1999 | K991085 | BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Long First (Xiamen) Co., Ltd. | accessdata.fda.gov |
| December 6, 1995 | K941258 | LATEX CONDOM | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
| November 8, 1995 | K946374 | KIMONO MICROTHIN | HIS | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| September 22, 1995 | K946376 | MAXX | HIS | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| September 22, 1995 | K943064 | KIMONO (CONDOMS) | HIS | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| January 6, 1994 | K925869 | SHEATHES, STERILE SHEATHES | ITX | Substantially Equivalent | Mayer Laboratories | accessdata.fda.gov |
| June 6, 1990 | K896987 | RUBBER CONDOM (NON-COLORED) | HIS | Substantially Equivalent | Hankook Latex Gongup Co., Ltd. | accessdata.fda.gov |
| May 16, 1990 | K897129 | CONDOMS (MULTIPLE BRANDS) | HIS | Substantially Equivalent | Sagami, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 7, 1993 | P910064 | F C FEMALE CONDOM | MBU | 13 | March 7, 1997 | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Patient
- All makers of Lubricant, Personal
- All makers of Condom
- All makers of Device, Incontinence, Urosheath Type, Sterile
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Latex Patient Examination Glove
Updated September 23, 2021. 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.