Panels › General Hospital › Product code LZC · Class 1
Medical Glove, Specialty
Regulation 880.6250
1510(k)s in 12 months (79 all time)
1recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in LZC
| Company | 510(k)s | Recalls |
|---|---|---|
| Wrp Asia Pacific Sdn. Bhd. | 5 | 0 |
| Ansell Healthcare Products LLC | 0 | 4 |
| Central Medicare Sdn Bhd | 4 | 0 |
| O&M Halyard, Inc. | 2 | 2 |
| Cardinalhealth | 3 | 0 |
| Perusahaan Getah Asas Sdn. Bhd. | 3 | 0 |
| Shen Wei (Usa), Inc. | 3 | 0 |
| Acufex Microsurgical, Inc. | 2 | 0 |
| Gmp Medicare Sdn Bhd (F25) | 2 | 0 |
| Guardian Group, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 2009 | K083409 | POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Jun 18, 2009 | K083305 | POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Dec 23, 2008 | K081971 | BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES Nitritex (M) Sdn. Bhd., MY | LZC |
| Jul 14, 2008 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM Kimberly-Clark Corp. | LZC |
| Mar 12, 2008 | K072197 | POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE COLOR; 9 AND 10 MILS AT FINGER, NATURAL COLOR Metacure Surgical Gloves Sdn Bhd, MY | LZC |
| Feb 27, 2007 | K062764 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED Kossan Latex Industries(M)Sdn Bhd, MY | LZC |
| Dec 16, 2004 | K042805 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE Perusahaan Getah Asas Sdn. Bhd., MY | LZC |
| May 7, 2004 | K033789 | LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING Cardinalhealth | LZC |
| Nov 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY Cardinalhealth | LZC |
| Oct 22, 2003 | K032374 | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED Perusahaan Getah Asas Sdn. Bhd. | LZC |
| Feb 15, 2001 | K010211 | STERILE NITRILE POWDER-FREE EXAMINATION GLOVES Allegiance Healthcare Corp. | LZC |
| Nov 1, 1999 | K990677 | ABSOGEL CHEMOTHERAPHY GLOVES Ampri Rubberware Industries Sdn Bhd, MY | LZC |
| Aug 30, 1999 | K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM Safeskin Corp. | LZC |
| Dec 23, 1998 | K982832 | PROGUARD, RR-1, RR-2 Emerson & Co. Srl, IT | LZC |
| Aug 25, 1997 | K970135 | NITRILE GLOVES Sage Products, Inc. | LZC |
| Dec 29, 1994 | K945577 | GUARDIAN II GLOVE Guardian Group, Inc. | LZC |
| Jul 8, 1994 | K942313 | GUARDIAN GLOVE Guardian Group, Inc. | LZC |
| Jun 22, 1993 | K920620 | FLUORO-SHIELD RADIATION REDUCTION GLOVES Acufex Microsurgical, Inc. | LZC |
| Mar 22, 1991 | K905527 | NEEDLESTICK PROTECTIVE GLOVE Medev Corp. | LZC |
| Jan 30, 1991 | K905177 | STAT(TM) GLOVE Success Builders Intl., Inc. | LZC |
| Oct 26, 1990 | K903142 | AUKUFLEX(TM) RADIATION RESISTANT GLOVES Aukland Mfg., Inc. | LZC |
| Mar 27, 1990 | K896759 | PB PLUS LEAD LATEX GLOVES Sistem Med-Pro (M) Sdn Bhd | LZC |
| Mar 15, 1990 | K895195 | CHEMO-TOUCH Medical Resources, Ltd. | LZC |
| Mar 9, 1990 | K895781 | ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES Ansell Intl., MT | LZC |
| Feb 13, 1990 | K893093 | FLOUROSHIELD RADIATION REDUCTION GLOVE Acufex Microsurgical, Inc. | LZC |
| Jan 4, 1990 | K896076 | L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) Advance Medical Designs, Inc. | LZC |
| Oct 5, 1989 | K891315 | ATTENUATING SURGICAL GLOVE F & L Medical Products Co. | LZC |
| May 22, 1989 | K891968 | ESP RADIATION REDUCTION EXAMINATION GLOVES Boston Scientific Corp | LZC |
| May 11, 1989 | K882437 | L3 (LEAD LATEX LYSNIG GLOVES) The Branford Co. | LZC |
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