Data / Medical devices / United States / Mexpo International, Inc.
Mexpo International, Inc.: FDA-registered device maker in Union City, CA, United States, 32 510(k) clearances
Mexpo International, Inc. is registered with the FDA (registration 2939935) in Union City, CA, United States. It lists 7 device types. The FDA files 32 510(k) clearances under its listings, the newest dated February 19, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2939935
- FEI number
- 1000124109
- Address
- 2828 Faber St, Union City, CA, United States, 94587
- Owner or operator
- MEXPO INTERNATIONAL, INC. (9000890)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 26, 2007
- Registered through
- 2027
- Brand names listed
- AAMEDIX Surgical Face Mask, Avianz® Surgical Face Mask, BLOSSOM, BLOSSOM® Surgical Face Mask, DISCOVERY2020, DISCOVERY2020® Surgical Face Mask, FRUTTI TREASURE, Frutti Treasure® Surgical Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dam, Rubber | EIE | 1 | Contract manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Patient Examination Glove | FMC | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 19, 2022 | K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
| December 13, 2021 | K210388 | Non Sterile Nitrile Powder Free Examination Gloves Blue, Green and Black color | LZA | Substantially Equivalent | Mexpo International, Inc. | accessdata.fda.gov |
| August 11, 2021 | K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| April 23, 2020 | K200847 | Surgical Face Mask | FXX | Substantially Equivalent | Mexpo International, Inc. | accessdata.fda.gov |
| March 5, 2018 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Central Medicare Sdn Bhd | accessdata.fda.gov |
| March 31, 2017 | K162626 | THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE | LZA | Substantially Equivalent | Top Quality Glove Sdn. Bhd | accessdata.fda.gov |
| November 2, 2016 | K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| April 23, 2015 | K150110 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| March 6, 2015 | K143419 | Patient Examination Gloves | LYY | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| January 16, 2015 | K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| September 12, 2014 | K140050 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 26, 2014 | K141021 | POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| July 11, 2014 | K140316 | EXAMINATION GLOVES | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| May 28, 2014 | K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 21, 2013 | K130038 | POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hl Rubber Industries Sdn Bhd | accessdata.fda.gov |
| September 11, 2012 | K113393 | POWDER FREE BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Tg Medical Sdn. Bhd. | accessdata.fda.gov |
| May 2, 2012 | K112924 | RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| March 2, 2012 | K113797 | DISPOSABLE VINYL EXAM GLOVE, POWDER FREE | LYZ | Substantially Equivalent | Full Synergy Medical Products, Inc. | accessdata.fda.gov |
| July 16, 2010 | K100603 | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Riverstone Resources Sdn Bhd | accessdata.fda.gov |
| June 25, 2010 | K100694 | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN | LYY | Substantially Equivalent | Tekmedic (M) Sdn Bhd | accessdata.fda.gov |
| May 18, 2009 | K090520 | STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
| May 8, 2009 | K090513 | VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) | LYZ | Substantially Equivalent | Shandong Huayue Glove Co., Ltd. | accessdata.fda.gov |
| November 18, 2005 | K052502 | NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| November 10, 2003 | K030583 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| September 10, 2001 | K011044 | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| March 30, 2001 | K010097 | POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 31, 2000 | K994354 | POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Flexitech Sdn. Bhd. | accessdata.fda.gov |
| April 2, 1999 | K990495 | POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Flexitech Sdn. Bhd. | accessdata.fda.gov |
| January 26, 1999 | K983145 | TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Shen Wei (Usa), Inc. | accessdata.fda.gov |
| January 25, 1999 | K984127 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | Kilang Barangan Getah Dioh | accessdata.fda.gov |
| May 6, 1997 | K970794 | LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) | LYY | Substantially Equivalent | Siam Sempermed Corp., Ltd. | accessdata.fda.gov |
| April 13, 1989 | K891356 | PATIENT EXAMINATION GLOVES (VINYL) | LYZ | Substantially Equivalent | Pm Gloves, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Mask, Surgical
- All makers of Latex Patient Examination Glove
- All makers of Patient Examination Glove
- All makers of Vinyl Patient Examination Glove
Updated February 19, 2022. 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.