510(k) K042238
- Device
- CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
- Applicant
- SEAL POLYMER INDUSTRIES BHD.
- 510(k) number
- K042238
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-09-16
- Date received
- 2004-08-18
- Regulation
- 880.6250
- Classification name
- Polymer Patient Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHUN CHOOI FONG
- Address
- Lot 72706,Jalan Lahat,Kawasan Perindustrian Bukit Merah Lahat, Perak MY 31500 31500
FDA Registration Numbers#
- 3011089435
- 3017114229
- 3018779144
- 3022543478
- 3014268334
- 3013496867
- 3005885230
- 3010811068
- 3011647251
- 3021591322
- 3024897455
- 3015997711
- 3042956952
- 8040880
- 3010621964
- 3014269027
- 3003887292
- 2084709
- 3004168786
- 3007842555
- 3014579161
- 3021641087
- 1250045
- 9617444
- 3015140351
- 3005024009
- 9681151
- 3011287770
- 3010175289
- 3026317063
- 3033715710
- 2435946
- 8040818
- 3017509841
- 3012441043
- 3042940407
- 3008261717
- 3011658061
- 3010363542
- 3011209798
- 3010194621
- 9616501
- 3031180726
- 3011689956
- 9681163
- 1833700
- 3018108902
- 1055236
- 3014819517
- 2026990
- 3011391433
- 3012314549
- 3016785252
- 3021286079
- 3009055041
- 3012494290
- 3007842585
- 3009540516
- 3025231442
- 3004995451
- 3006534695
- 3008253024
- 3021640893
- 3009474977
- 1937310
- 3017887964
- 3007392007
- 3015335034
- 3016785267
- 8041150
- 3015219124
- 3011191255
- 3021015522
- 3005012805
- 1423537
- 3038276166
- 3008489813
- 1222115
- 3042765418
- 3018167658
Source Documents#
Other 510(k) Records For Product Code LZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
| K252549 | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | 2026-01-13 |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | 2025-11-17 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | 2025-10-23 |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | 2025-10-17 |
| K251716 | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | 2025-08-27 |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | 2025-08-21 |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | 2025-08-18 |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Hartalega NGC Sdn. Bhd. | 2025-07-30 |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology, Inc. | 2025-07-09 |
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Encompass Industries Sdn. Bhd. | 2025-07-08 |
| K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Zibo Shengkun Chemical Industry Co., Ltd. | 2025-07-07 |
| K243172 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | O&M Halyard, Inc. | 2025-06-18 |
Legacy Summary#
summary
FDA Review#
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