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510(k) Data Aggregation

K Number

K021492

Device Name

K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT

Manufacturer

PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.

Date Cleared

2002-08-07

(90 days)

Product Code

NUC

Regulation Number

884.5300

Intended Use

Personal Lubricant (compatible with latex condoms)

Device Description

K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

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K Number

K020827

Device Name

K-Y BRAND ULTRA GEL PERSONAL LUBRICANT

Manufacturer

PERSONAL PRODUCTS CO., DIV. OF MCNEIL PPC, INC.

Date Cleared

2002-06-12

(90 days)

Product Code

NUC

Regulation Number

884.5300

Intended Use

Personal Lubricant compatible with latex condoms, helps enhance intimacy

Device Description

K-Y® Brand Ultra Gel™ is a non-sterile water- based personal lubricant designed to supplement the body's own natural lubrication fluids. This formula is a clear, non-irritating, non-greasy, non-staining, high viscosity liquid gel. This highly lubricous product may be used with or without a latex condom during intimate sexual activity. K-Y® Brand Ultra Gel™ is not a contraceptive or spermicide. It is however, compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

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