P.T. Maja Agung Latexindo
SUNGGAL DELI SERDANG Sumatera Utara, ID
P.T. MAJA AGUNG LATEXINDO appears in FDA device records in SUNGGAL DELI SERDANG Sumatera Utara, ID. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for P.T. Maja Agung Latexindo between 1990 and 2022. The busiest year on record is 2000, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 2 |
| 2006 | 1 |
| 2008 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | LZA | Substantially Equivalent | |
| K161099 | Powder Free Nitrile Examination Gloves, Black | LZA | Substantially Equivalent | |
| K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | LYY | Substantially Equivalent | |
| K062709 | POWDER FREE LATEX EXAMINATION GLOVES, BLACK | LYY | Substantially Equivalent | |
| K020040 | LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM | LYY | Substantially Equivalent | |
| K013996 | LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE | LYY | Substantially Equivalent | |
| K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K994255 | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | LYY | Substantially Equivalent | |
| K992752 | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 | KGO | Substantially Equivalent | |
| K982897 | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K896604 | MAL LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8041150 | 3000239897 | P.T. MAJA AGUNG LATEXINDO | JL.UTAMA NO.98 PUJI MULIO, SUNGGAL DELI SERDANG Sumatera Utara 20352 ID | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain