POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE

K123749 · Kossan Latex Industries(M)Sdn Bhd · LZA · Mar 1, 2013 · General Hospital

Device Facts

• Record ID: K123749
• Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
• Applicant: Kossan Latex Industries(M)Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Mar 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Device Story

Disposable nitrile patient examination glove; worn by clinicians to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Green, non-sterile, powder-free. Low dermatitis potential labeling claim supported by human clinical testing. Used in clinical settings; provides barrier protection during patient examinations and handling of chemotherapy agents.

Clinical Evidence

Clinical evidence provided via Modified Draize-95 Test for skin sensitization. Study conducted on 200 non-sensitized adult human subjects. Results showed no clinical evidence of residual chemical additives capable of inducing Type IV allergy. No primary skin irritation observed.

Technological Characteristics

Nitrile material; powder-free; green color; non-sterile. Complies with ASTM D6319-10 (dimensions, physical properties), ASTM D5151-11 (pinholes), and ASTM D6124-11 (powder residue). Biocompatibility per ISO 10993-10:2010 and 16 CFR Part 1500.41. Chemotherapy resistance per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs (Dacarbazine, Cyclophosphamide, Doxorubicin HCl, Fluorouracil, Cisplatin, Etoposide, Paclitaxel, Thiotepa). Warning: Do not use with Carmustine.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Powder Free Nitrile Patient Examination Glove, Blue, White, Green (K120066)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Kossan Latex Industries. The logo includes the letters "KL1" in a bold, black font on the left side of the image. To the right of the letters, the text "KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)" is displayed in a smaller, serif font.

# FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information

#### 1.0 Submitter:

Kossan Latex Industries (M) Sdn Bhd Lot 6129, Jalan Haji Abdul Manan, Batu 5 1/4, Jalan Meru, Klang, 41050 Selangor, Malaysia

Telephone No .: [phone] Fax No .: [phone]

#### 2.0 Contact Person:

| Contact: | Ms S F Cho |
|----------------|----------------|
| Telephone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Preparation Date: 29 November 2012

#### 4.0 Name of Device:

Trade Name: Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim.

Powder-Free Nitrile Patient Examination Glove Common Name: Classification Name: Patient Examination Glove (21 CFR Part 880.6250) Regulatory Class: Class I Product Code: 80 LZC, 80 LZA.

#### 5.0 Identification of the Legally Marketed Device:

Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim; Class I Patient Examination Gloves, Nitrile-80LZA, 80LZC, meets all of the requirements of ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Predicate Device: K120066, Powder Free Nitrile Patient Examination Glove, Blue, White, Green. Non-Sterile. Low Dermatitis Potential Labeling Claim.

Image /page/0/Picture/14 description: The image shows the text "Page 1 of 6". This text indicates that the image is the first page of a document that has a total of six pages. The text is written in a simple, sans-serif font and is positioned at the top of the image.

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#### K L 1 KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

#### 6.0 Description of Device:

Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, meets all of the requirements of ASTM D 6319-10.

#### 7.0 Intended Use of the Device:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This glove has been tested for use with specific chemotherapy drugs listed below.

Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in Minutes)

| Dacarbazine (DTIC) (10.0 mg/ml) | > 240 |
|-----------------------------------------|-------|
| Carmustine (BCNU) (3.3 mg/ml) | 15.3 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 195.8 |

Warning: Do not use with Carmustine.

#### 8.0 Summary of the Technological Characteristics of the Device:

Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim possess the following technological characteristic (as compared to ASTM or equivalent standards):

| Characteristic | Standards | Device Performance |
|----------------------------|--------------------------------------------------------------------|-------------------------------|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pin-<br>holes | ASTM D 5151-11 | Meets |
| | ASTM D 6319-10 | Meets |
| Powder Free Residue | ASTM D 6124-11 | Meets |
| | ASTM D 6319-10 | Meets |
| Biocompatibility | Dermal Sensitization<br>(as per ISO 10993-<br>10:2010) | Not a contact skin sensitizer |
| | Primary Skin<br>Irritation Test<br>(as per 16 CFR Part<br>1500.41) | Not a primary skin irritant |

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# KOSSAN LATEX INDUSTRIES (M) SDN. BHD. (169832-K)

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