Data / Medical devices / Malaysia / Maxwell Glove Manufacturing Bhd
Maxwell Glove Manufacturing Bhd: FDA-registered device maker in KAMUNTING Perak, Malaysia, 6 510(k) clearances
Maxwell Glove Manufacturing Bhd is registered with the FDA (registration 3004939660) in KAMUNTING Perak, Malaysia. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 6, 2005. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004939660
- Address
- Plot 116 & 117, Jalan Logam 7, Kawasan Perindustrian Kamunting Raya 3., KAMUNTING Perak, Malaysia, 34600
- Owner or operator
- MAXWELL GLOVE MANUFACTURING BHD (9010439)
- Roles
- Manufacturer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- Seal Polymer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| December 6, 2005 | K050526 | POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR | LYY | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| May 19, 2005 | K050528 | POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK) | LZA | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| April 14, 2005 | K050532 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA | LYY | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| March 18, 2005 | K050531 | POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) | LZA | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| March 18, 2005 | K050527 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL | LYY | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
| March 16, 2005 | K050529 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER | LYY | Substantially Equivalent | Spi Gloves Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated December 6, 2005. 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.