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Lubricant, Patient

FDA product code KMJ · 47 cleared devices

Class 1 General Hospital

Regulation: 21 CFR 880.6375
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-06-20 – 2013-10-03

KMJ 2013-10-03

COLONGLIDE(R) LUBRICANT

Applicant Pediatric Pharmaceuticals, Inc.

K number K131617

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KMJ 2012-08-10

LUBE JELLY SURINGE

Applicant Nurse Assist, Inc.

K number K121390

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KMJ 2012-05-04

DUKAL LUBRICATING JELLY

Applicant Dukal Corporation

K number K113689

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KMJ 2012-04-10

STERILE LUBRICATING JELLY

Applicant Jianerkang Medical Dressing Company

K number K112110

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KMJ 2011-05-10

DYNACOR LUBRICATION GEL

Applicant Medline Industries, Inc.

K number K103718

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KMJ 2010-12-23

ULTRA SEAL STERILE LUBRICATING JELLY

Applicant Ultra Seal Corporation

K number K101522

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KMJ 2009-12-18

DYNAREX STERILE LUBRICATING JELLY

Applicant Dynarex Corporation

K number K092488

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KMJ 2008-11-21

STERI-LUB LUBRICATION GEL

Applicant Avail Medical Products, Inc.

K number K083189

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KMJ 2008-05-22

SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL

Applicant Sheffield Industries, Div. of Faria , Ltd.

K number K073684

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KMJ 2008-04-03

SPIRUS MEDICAL SURGICAL INSTRUMENT

Applicant Spirus Medical, Inc.

K number K080042

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KMJ 2005-02-23

DUREX PLAY WARMER LUBRICANT

Applicant Ssl Americas, Inc.

K number K042563

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KMJ 2004-05-07

E-Z LUBRICATING JELLY

Applicant Chester Labs, Inc.

K number K041060

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KMJ 2003-01-24

GOOD LUBRICATIONS

Applicant Biofilm, Inc.

K number K020586

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KMJ 1998-01-16

PDI STERILE LUBRICATING JELLY

Applicant Nice-Pak Products, Inc.

K number K974768

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KMJ 1997-10-10

LUBRIGLIDE

Applicant Qualis, Inc.

K number K973557

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KMJ 1996-07-18

LUBRICATING JELLY, LOW VISCOSITY

Applicant Span-America Medical Systems, Inc.

K number K961502

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KMJ 1996-06-26

EVRON GEL

Applicant Pharmaceutical Innovations, Inc.

K number K961222

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KMJ 1995-07-21

AQUAGEL LUBRICATING JELLY

Applicant Depuy Healthcare

K number K951431

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KMJ 1995-07-19

MAXILUBE

Applicant Mission Pharmacal Co.

K number K943010

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KMJ 1995-02-27

STERI-LUB LUBRICATION GEL

Applicant Horizon Medical, Inc.

K number K944969

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KMJ 1994-02-18

ASTROGLIDE

Applicant Biofilm, Inc.

K number K935299

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KMJ 1993-02-19

COMFORT PERSONAL LUBRICANT

Applicant Hyman, Phelps & McNamara, P.C.

K number K915574

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KMJ 1991-09-27

OPERAND LUBRICATING JELLY

Applicant General Medical Co.

K number K912975

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KMJ 1991-05-03

MENTOR LUBRICATING JELLY

Applicant Mentor Corp.

K number K910790

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KMJ 1990-10-26

LUBRICATING JELLY

Applicant Lake Pharmaceutical, Inc.

K number K903910

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KMJ 1990-09-06

DISPENSA-LUBE

Applicant Gam-Med Packaging Corp.

K number K903717

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KMJ 1990-05-02

OPERAND* LUBRICATING JELLY

Applicant General Medical Co.

K number K900110

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KMJ 1989-12-01

OSBON PERSONAL LUBRICANT

Applicant Osbon Medical Systems, Ltd.

K number K896207

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KMJ 1989-12-01

OSBON PERSONAL LUBRICANT

Applicant Osbon Medical Systems, Ltd.

K number K895406

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KMJ 1988-09-09

MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0

Applicant Span-America Medical Systems, Inc.

K number K882506

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KMJ 1988-05-16

CONDOM-MATE VAGINAL LUBRICANT

Applicant Upsher-Smith Laboratories, Inc.

K number K881338

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KMJ 1987-06-12

K-GEL

Applicant Taro Pharmaceuticals, Inc.

K number K872128

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KMJ 1987-06-05

AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G

Applicant Span-America Medical Systems, Inc.

K number K870742

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KMJ 1987-04-01

LUBRICATING JELLY

Applicant H & P Industries, Inc.

K number K871169

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KMJ 1986-12-01

AQUALUBE(TM)

Applicant Parker Laboratories, Inc.

K number K864556

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KMJ 1985-12-10

STERILE SALINE SOLUTION

Applicant I M, Inc.

K number K854155

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KMJ 1985-11-13

SANA-LUBE

Applicant Huntington Laboratories, Inc.

K number K853653

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KMJ 1985-06-06

TODAY PERSONAL LUBRICANT

Applicant Vli Corp.

K number K851617

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KMJ 1982-07-30

TOMAC LUBRICATING JELLY

Applicant American Medical Systems, Inc.

K number K822143

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KMJ 1982-03-26

WET PACK LINE OF PRODUCTS

Applicant Abco Dealers, Inc.

K number K820587

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KMJ 1981-09-28

A.D.T. PROCEDURES TRAY

Applicant A.D.T. Lab Industries

K number K812297

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KMJ 1981-04-21

K-Y LUBRICATING JELLY

Applicant Johnson & Johnson Professionals, Inc.

K number K810310

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KMJ 1981-04-21

PEDICAT*

Applicant Pollak (Intl.), Ltd.

K number K810049

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KMJ 1979-11-16

HYGENIC RUBBER DAM LUBRICANT

Applicant The Hygenic Corp.

K number K791970

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KMJ 1979-08-03

LUBRICATING JELLY

Applicant Abco Dealers, Inc.

K number K791243

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KMJ 1979-02-01

LUBRICANT, OTRHO PERSONAL

Applicant Ortho Pharmaceutical Corp.

K number K790087

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KMJ 1977-06-20

PRESERVE LUBRICANT CODE NO. 43=4035

Applicant Codman & Shurtleff, Inc.

K number K770498

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