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Panels › General Hospital › Product code LZA · Class 1

Polymer Patient Examination Glove

Regulation 880.6250

17510(k)s in 12 months (1,182 all time)
3recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in LZA

Company510(k)sRecalls
Shen Wei (Usa), Inc.340
Hartalega Sdn Bhd330
Hartalega NGC Sdn. Bhd.240
Smart Glove Corp. Sdn Bhd190
Siam Sempermed Corp., Ltd.170
Yty Industry (Manjung) Sdn Bhd170
Gx Corporation Sdn Bhd150
Wrp Asia Pacific Sdn. Bhd.150
Eco Medi Glove Sdn. Bhd.140
O&M Halyard, Inc.140
Decided510(k)Device and applicantCode
Oct 12, 2017K171874Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Dr
Hartalega Sdn Bhd, MY
LZA
Oct 12, 2017K171782Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs
Blue Sail Medical Co.,Ltd, CN
LZA
Sep 26, 2017K172015POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Careglove Global Sdn. Bhd., MY
LZA
Sep 20, 2017K171541Powder Free Nitrile Examination Gloves (Orange)
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Sep 14, 2017K171378Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
Semperit Investments Asia Pte , Ltd., SG
LZA
Sep 8, 2017K171667Powder Free Nitrile Examination Glove
Professional Latex Sdn Bhd, MY
LZA
Aug 25, 2017K171104Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Aug 25, 2017K170136Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Shandong Feiyang Professional Gloves Co., Ltd., CN
LZA
Jul 31, 2017K171615Xingyu Nitrile Powder Free Patient Examination Gloves, White color
Shandong Xingyu Gloves Co., Ltd., CN
LZA
Jul 25, 2017K162312Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
Shen Wei USA, Inc.
LZA
Jul 20, 2017K171616Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
Shandong Xingyu Gloves Co., Ltd., CN
LZA
Jul 19, 2017K171093STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
Sanrea Healthcare Products Pvt, Ltd., IN
LZA
Jul 18, 2017K162510Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Ug Global Resources Sdn. Bhd., MY
LZA
Jul 14, 2017K170686Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
Brightway Holdings Sdn. Bhd., MY
LZA
Jul 10, 2017K170397Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemothera
Kossan International Sdn Bhd, MY
LZA
Jul 7, 2017K171339EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
Eco Medi Glove Sdn. Bhd., MY
LZA
Jul 7, 2017K163035DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
Elm Tree Medical, Inc.
LZA
Jun 30, 2017K170794Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
Hartalega NGC Sdn. Bhd., MY
LZA
May 24, 2017K170290Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
Shen Wei USA, Inc.
LZA
May 22, 2017K163553Powder Free Nitrile Patient Examination Gloves, Blue
Hebei Titans Medical Supply Technology Group., Ltd., CN
LZA
May 9, 2017K170393Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
Zibo Chengxun Automatic Device Co., Ltd., CN
LZA
Apr 21, 2017K162294BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Brightway Holdings Sdn. Bhd., MY
LZA
Mar 31, 2017K162626THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
Top Quality Glove Sdn. Bhd, MY
LZA
Mar 29, 2017K161929Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
Dipped Products (Thailand) Limited, TH
LZA
Mar 28, 2017K162405Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitril
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Mar 24, 2017K163267NITRILE EXAMINATION GLOVE
Brightway Holdings Sdn. Bhd., MY
LZA
Mar 3, 2017K162646Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Hartalega NGC Sdn. Bhd., MY
LZA
Feb 27, 2017K162982Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.
LZA
Feb 23, 2017K161099Powder Free Nitrile Examination Gloves, Black
Pt. Maja Agung Latexindo, ID
LZA
Feb 22, 2017K163126Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
Blue Sail Medical Co.,Ltd, CN
LZA
Feb 22, 2017K163041Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
Pt. Medisafe Technologies, ID
LZA
Feb 8, 2017K162491Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
Hartalega Sdn Bhd, MY
LZA
Feb 6, 2017K162923NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATIO
Hartalega NGC Sdn. Bhd., MY
LZA
Jan 31, 2017K162381HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs
Healthy Glove Co., Ltd., TH
LZA
Jan 24, 2017K162924Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blu
Hartalega Sdb. Bhd., MY
LZA
Jan 9, 2017K162819Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Hartalega Sdn Bhd, MY
LZA
Jan 9, 2017K162818Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bl
Hartalega Sdn Bhd, MY
LZA
Jan 5, 2017K162146Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
Brightway Holdings Sdn. Bhd., MY
LZA
Dec 21, 2016K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
Brightway Holdings Sdn. Bhd., MY
LZA
Nov 28, 2016K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
Terang Nusa Sdn Bhd, MY
LZA
Nov 21, 2016K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Shandong Baisheng Medical Products Co., Ltd., CN
LZA
Nov 17, 2016K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
Shen Wei (Usa), Inc.
LZA
Nov 7, 2016K162113Powder Free Nitrile Examination Gloves (Blue)
Nam Viet Glove Joint Stock Company, VN
LZA
Nov 2, 2016K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Oct 20, 2016K161422DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Oct 19, 2016K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
Medline Industries, Inc.
LZA
Oct 13, 2016K160562Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Hartalega Snd. Bhd., MY
LZA
Sep 9, 2016K161187EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
Eco Medi Glove Sdn. Bhd., MY
LZA
Sep 1, 2016K161320EMG Pink Nitrile Examination Glove Powder Free
Eco Medi Glove Sdn. Bhd., MY
LZA
Aug 4, 2016K160560Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bl
Hartalega Sdn Bhd, MY
LZA

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