510(k) K942313
- Device
- GUARDIAN GLOVE
- Applicant
- GUARDIAN GROUP, INC.
- 510(k) number
- K942313
- Product code
- LZC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-07-08
- Date received
- 1994-05-13
- Regulation
- 880.6250
- Classification name
- Patient Examination Glove, Specialty
- 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
- RON MELTON
- Address
- 8656-5 Villa La Jolla Dr. La Jolla CA US 92037 92037
FDA Registration Numbers#
- 3008298053
- 2939388
- 3028652705
- 1000121056
- 3006534695
- 3019849096
- 3013428737
- 3030671502
- 3010419931
- 3014819517
- 1043549
- 3009538921
- 1058397
- 3004168786
- 3012341425
- 3004513970
- 9614175
- 3044026004
- 2939935
- 3021591319
- 1928237
- 3017616393
- 1921846
- 3011287770
- 3026263452
- 9681163
- 3019798835
- 3005595283
- 3018108902
- 9614502
- 3008700497
- 3008253024
- 3010220595
- 1423537
- 3011200663
- 3011189071
- 3021827562
- 3020521811
- 3011089435
- 3030419987
- 3021841055
- 3017171460
- 3044819802
- 3015335034
- 3010966951
- 3011050560
- 3008604557
- 3002807090
- 3010273867
- 3005022483
- 1119294
- 3003744503
- 3015335977
- 3004553390
- 3038592309
- 3017887964
- 3024706752
- 3004577220
- 3010195579
- 3012441043
- 3011862887
- 2032521
- 3019252794
- 3016866909
- 1643817
- 9681260
- 3015142965
- 3024755882
- 3009429841
- 3024897455
- 3002806603
- 3010436932
- 3038277359
- 3021206556
- 3025303965
- 3011391433
- 3014579161
- 3026363353
- 3019840054
- 3015422337
Source Documents#
Other 510(k) Records For Product Code LZC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | 2026-01-14 |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | 2025-02-24 |
| K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-08-30 |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | Better Care Plastic Technology Co., Ltd. | 2022-08-27 |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | Hl Rubber Industries Sdn Bhd | 2022-05-26 |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | Hainan Asther Medical Equipment Co., Ltd. | 2022-05-14 |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs | Niujian Technology Co., Ltd. | 2022-03-31 |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs | Changzhou Universal Medical Equipment Co., Ltd. | 2022-03-10 |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs | Anhui Xinyisheng Medical Technology Co.,Ltd | 2022-01-28 |
| K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | 2021-12-20 |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | Jiangsu Nanfang Medical Co., Ltd. | 2021-12-08 |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2021-12-06 |
| K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | 0 & M Halyard, Inc. | 2020-10-11 |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industires, Inc. | 2020-09-18 |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp | 2020-06-04 |
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