POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1

K101106 · Best Putra Gloves Sdn Bhd · LYY · Nov 10, 2010 · General Hospital

Device Facts

• Record ID: K101106
• Device Name: POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
• Applicant: Best Putra Gloves Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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.

Device Story

Disposable powdered natural latex examination glove; worn on examiner's hand/finger; acts as physical barrier to prevent cross-contamination between patient and examiner; used in clinical/medical settings; non-sterile; single-use.

Clinical Evidence

No clinical data; bench testing only. Performance verified against ASTM D 3578-01a standards for dimensions, physical properties, pinhole freedom, powder content, and water-soluble protein content. Biocompatibility testing (primary skin irritation and dermal sensitization) confirmed no adverse reactions.

Technological Characteristics

Natural rubber latex; powdered; non-sterile. Dimensions and physical properties meet ASTM D 3578-01a. Powder content <10 mg/dm² (ASTM D 6124-05). Water-soluble protein content <200 ug/dm² (ASTM D 5712-99). Biocompatibility: pass (no primary skin irritation or dermal sensitization).

Indications for Use

Indicated for use by medical personnel as a disposable barrier worn on the hand or finger to prevent cross-contamination between patient and examiner.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black, and the background is white. The letters are slightly distressed, with some small imperfections and rough edges.

### I PUTRA GLUVES SUN.BHD. (580515-T)

& 1358, Jin Kg. Mohd Taib, Kawas 3000 Rawang, Selangor Da +03-6092 1042 +03-6092 1142 Fax: +0 E-mail : [e-mail] Website

Image /page/0/Picture/3 description: The image contains two sets of logos. The first set includes the "nqa. ISO 9001 Registered" logo and the "UKAS ENVIRONMENTAL MANAGEMENT 015" logo. The second set includes the "nqa. ISO 14001 Registered" logo and the "UKAS ENVIRONMENTAL MANAGEMENT 015" logo.

# <101106

### 510 (K) SUMMARY

#### 1.0 Submitter:

NOV 1 0 2010

0143

| Name | : Ratnam S.Vythilingam |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | : Best Putra Gloves Sdn Bhd, Jln Kg Mohd Taib, Kawasan Perindustrian Sg Choh, 48000, Rawang, Selangor Darul Ehsan. Malaysia |
| Phone No. | : +03-60921042 |
| Fax No. | : +03-60912820 |

Date of Summary Prepared: 20 August 2010

#### 2.0 Contact Person:

| Name | Dr. Effendi Tenang |
|-----------|--------------------|
| Phone No. | +03-60921042 |
| Fax No. | +03-60912820 |

#### 3.0 Name of the device:

| Trade Name | : 1) BPG Latex Examination Gloves<br>2) Multiple or Customers' Trade Name |
|---------------------|---------------------------------------------------------------------------|
| Device Name | : Powdered, Natural Color, Latex Examination Gloves,<br>Non-Sterile |
| Common Name | : Examination Gloves |
| Classification Name | : Patient Examination Gloves (Class 1) |

#### 4.0 Identification of the legally marketed device:

Class I patient examination gloves, powdered, that meets all the requirements of
ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

#### 5.0 Description of the Device:

The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.

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Image /page/1/Picture/0 description: The image shows the letters 'BPG' in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, giving them a rough or worn look. The letters are large and take up most of the frame.

(580515-1)
Lot 1357 & 1358, Jln Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh
48000 Rawang, Selangor Darul Ehsan, Malaysia.
Tel: [phone] Fax: [phone]
E-mail : [e-mail] Website : www.bpgloves.com

Image /page/1/Picture/2 description: The image contains two sets of logos related to quality and environmental management systems. The first set includes the "nqa. ISO 9001 Registered" logo and the "UKAS" logo with the number "015" below it. The second set includes the "nqa. ISO 14001 Registered" logo and the "UKAS" logo with the number "015" below it. The logos suggest that the organization has been certified for both ISO 9001 (quality management) and ISO 14001 (environmental management) standards by an accredited body.

K101106

#### 6.0 Intended Use of the Device:

A 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.

#### 7.0 Summary of the technological characteristic of the devices:

The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile are summarized with following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|-----------------------|------------------------------|
| Dimensions | D 3578-01at | Meets |
| Physical Properties | D 3578-01a€ | Meets |
| Freedom from Pinhole | D 3578-01a84 | Meets |
| | FDA CFR 800.20 | |
| Powder Amount | D 3578-01a64 | <10 mg/dm- |
| | D 6124 - 05 | |
| Water Soluble Protein | D 3578-01a84 | <200 ug/dm² |
| Content | D 5712-99 | |
| Biocompatability | Primary Skin | Pass |
| | Irritation in Rabbits | (No primary skin irritation) |
| | Dermal Sensitization | Pass |
| | | (No contact sensitizer) |

#### 8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data.

The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

#### 9.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data.

Clinical data is not needed for gloves or for most devices cleared by the 510 (k) process.

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Image /page/2/Picture/0 description: The image shows the letters 'BPG' in a bold, sans-serif font. The letters are black and have a distressed or grunge texture, giving them a worn or aged appearance. The letters are large and take up most of the frame.

## BESI PUIKA GLOVES SDN.BHD. (580515-T)

Lot 1357 & 1358, Jin Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darui Ehsan, Malaysia. Tel: [phone] Fax: +03-6091, 2820 E-mail : [e-mail] Website : www.bpgloves.com

Image /page/2/Picture/3 description: The image contains two sets of logos related to quality and environmental management systems. The first set includes the "nqa. ISO 9001 Registered" logo alongside the UKAS (United Kingdom Accreditation Service) environmental management logo with the number 015. The second set features the "nqa. ISO 14001 Registered" logo, also accompanied by the UKAS environmental management logo with the same number 015, indicating certification or registration under these standards.

K101106
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#### 10.0 Conclusion

It can be concluded that the Powdered , Natural Color, Latex Examination Gloves, Non-Sterile will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for Water Leak Test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Effendi Tenang Managing Director Best Putra Gloves SDN BHD Lot 1357-1358, JLN Kg. Mohd Taib Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia

NOV 1 0 2010

Re: K101106

Trade/Device Name: Powdered, Latex Examination Gloyes, Natural Color, Non-Sterile Model: MEP1 Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 4, 2010 Received: October 21, 2010

Dear Dr. Tenang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, , that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

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Page 2- Dr. Tenang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Seren Luures

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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Image /page/5/Picture/0 description: The image shows the letters "BPG" in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are solid black, and the background is white.

T PUTRA GLOVES SDN.BF

Lot 1357 & 1358, Jln Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh,
48000 Rawang, Selangor Darul Ehsan, Malaysia.
Tel: [phone] Fax: [phone]
E-mail: [e-mail] Website: www.bpgloves.com

Image /page/5/Picture/3 description: The image shows two sets of logos. The first set includes a logo with the text "nga. ISO 9001 Registered" and another logo with a checkmark and the number "015". The second set includes a logo with the text "ISO 14001 Registered" and another logo with a checkmark and the number "015".

1 0 2019

## INDICATIONS FOR USE

510( k ) Number: K101106

Device Name: Powdered, Latex Examination Glove, Natural Color, Non-Sterile, Model: MEP1

Indications For Use:

A 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.

Sincerely

Dr. Effendi Tenang

(Managing Director)

Prescription Use_ (Part 21 CFR 801 Subpart D)

OR

Over - The - Counter Use _XXX_ (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _

Elaine S. Mayhall

Offision Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Seneral Section of Anesthesionogy, General Devices Division of Anesthoolor

510(k) Number: K101106