Data / Medical devices / Thailand / SGMP Co., Ltd.
SGMP Co., Ltd.: FDA-registered device maker in Hatyai Songkhla, Thailand, 32 510(k) clearances
SGMP Co., Ltd. is registered with the FDA (registration 9615905) in Hatyai Songkhla, Thailand. It lists 3 device types. The FDA files 32 510(k) clearances under its listings, the newest dated September 12, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9615905
- FEI number
- 3003069816
- Address
- 181 Moo 6, Tambol Kampaengphet Amphur Rattaphum, Hatyai Songkhla, Thailand, 90180
- Owner or operator
- SGMP CO., LTD. (9040031)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 29, 1999
- Registered through
- 2027
- Brand names listed
- Blue Bubble Gum, Bubble Gum, P-F Pink/Cherry, P-F Purple/Grape, P.F Blue/CHEMO, Powder Free Nitrile Blue Indigo 6 mil 9.5, Powder-Free Nitrile Blue Vanilla, Powder-Free Nitrile Left/Right and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 12, 2012 | K112693 | NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| November 19, 2010 | K101822 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZC | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| September 8, 2010 | K101646 | NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR | LZA | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| March 27, 2008 | K072403 | NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| March 27, 2008 | K072400 | NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| March 21, 2008 | K072406 | NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| July 26, 2007 | K071060 | NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| September 1, 2005 | K052016 | NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| January 13, 2005 | K042879 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING | LZA | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| November 20, 2003 | K023537 | NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| August 28, 2003 | K032294 | NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| August 28, 2003 | K032293 | NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| June 12, 2003 | K030994 | NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| June 12, 2003 | K030993 | NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| February 14, 2002 | K020317 | NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE | LZA | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| December 3, 2001 | K013288 | NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| September 21, 2001 | K012863 | NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| September 21, 2001 | K012860 | POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| September 21, 2001 | K012857 | NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| June 7, 2001 | K011377 | NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| June 7, 2001 | K011371 | NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| June 7, 2001 | K011370 | NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| February 9, 2001 | K010095 | NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| July 31, 2000 | K002176 | NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| July 31, 2000 | K002175 | NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| April 21, 2000 | K000867 | POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| April 20, 2000 | K000868 | NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| April 12, 2000 | K000391 | VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| April 12, 2000 | K000390 | VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| March 29, 2000 | K000671 | POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| March 20, 2000 | K000488 | VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB | LYY | Substantially Equivalent | Sgmp Co., Ltd. | accessdata.fda.gov |
| September 8, 1995 | K953496 | ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Shield Gloves Manufacturer (M) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
Updated September 12, 2012. 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.