510(k) K170397
- Device
- Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested For Use With Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested For Use With Chemother
- Applicant
- Kossan International Sdn. Bhd.
- 510(k) number
- K170397
- Product code
- LZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-10
- Date received
- 2017-02-09
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Cho Sow Fong
- Address
- Wisma Kossan, Lot 782, Jalan Sungai Putus, Off Batu 3 3/34, Jalan Kapar, Klang MY 42100 42100
FDA Registration Numbers#
- 3013428737
- 3033715710
- 3013565389
- 3014269027
- 3003887292
- 3009659860
- 3018779144
- 3010201834
- 3015727296
- 3030187570
- 3035455506
- 3034618336
- 3047897192
- 3028162329
- 3045855232
- 3005885230
- 2938651
- 3016759113
- 9613997
- 3005034064
- 3043226252
- 3031181949
- 3011427127
- 3014743234
- 3017887964
- 3010436932
- 3009176340
- 3038187455
- 3010194621
- 3006534695
- 3012924721
- 3013514660
- 3044026004
- 3003699698
- 1222115
- 3013546437
- 3026263452
- 3006979699
- 3010830834
- 3000247873
- 3031288561
- 3011647251
- 3016685880
- 1423537
- 3042940407
- 9615095
- 9616896
- 1038758
- 3004111573
- 3008298053
- 3013034812
- 3038185756
- 1055236
- 2648727
- 3016601021
- 3030447506
- 3012494290
- 3005568780
- 9710583
- 3017929385
- 3038187456
- 3007829481
- 1219821
- 9613494
- 2026990
- 3020764656
- 3003895865
- 3036781051
- 1417592
- 3004939660
- 3038284237
- 3024712919
- 9680794
- 1043549
- 3038276166
- 8040614
- 3021286079
- 3038592309
- 9681247
- 3043739177
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LZA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253508 | Powder Free Nitrite Examination Glove, Cobalt Blue. Violet Blue and White. Non-Sterile | Vietglove Corporation | 2026-10-29 |
| K262208 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid – Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink | Yty Industry (Manjung) Sdn Bhd | 2026-10-01 |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | 2026-09-09 |
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | 2026-09-09 |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | 2026-09-08 |
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | 2026-09-02 |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | 2026-08-18 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | 2026-07-21 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | Hartalega NGC Sdn. Bhd. | 2026-07-20 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026-06-18 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | 2026-06-17 |
| 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 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026-06-03 |
| K253160 | Syntex Exam Gloves | Basic Medical Technology, Inc. | 2026-01-23 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases