MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES

K110250 · Total Gloves Sdn Bhd · LYY · Oct 14, 2011 · General Hospital

Device Facts

• Record ID: K110250
• Device Name: MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES
• Applicant: Total Gloves Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Oct 14, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Device Story

MPXX™ Powder Free Natural Rubber Latex Examination Gloves are non-sterile, single-use patient examination gloves. Manufactured from natural rubber latex; processed via multiple washing and rinsing to achieve powder-free status. Used in clinical settings by healthcare personnel to provide a barrier against contamination between the wearer and the patient. Device functions as a physical barrier; no electronic or software components. Performance verified against ASTM D 3578-05 standards for physical dimensions, tensile strength, and biocompatibility.

Clinical Evidence

No clinical tests were conducted. Evidence consists of bench testing per ASTM D 3578-05 and 21 CFR 800.20, including physical property testing (thickness, length, tensile strength), freedom from holes (AQL 1.5), and biocompatibility (primary skin irritation and delayed contact sensitization).

Technological Characteristics

Material: Natural rubber latex. Form factor: Powder-free, non-sterile examination glove. Standards: Meets ASTM D 3578-05. Physical properties: Palm/finger thickness ≥ 0.08mm, length ≥ 240mm, tensile strength ≥ 18MPa, elongation ≥ 650%. Protein content: ≤ 50 µg/dm². Biocompatibility: Passes primary skin irritation and dermal sensitization tests.

Indications for Use

Indicated for single use by healthcare and similar personnel to prevent cross-contamination between personnel and patients. No specific age or gender restrictions; contraindications not specified.

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

• Qtexx Powder-Free Latex Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram (K981767)

Submission Summary (Full Text)

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# K110250

#

OCT 1 4 2011

### MPXX™ POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES

| Submitter's Name | TOTAL GLOVE COMPANY SDN. BHD. |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | Lot 2584, Jalan Perusahaan 3,<br>Kamunting Industrial Estate<br>34600 Taiping, Perak,<br>Malaysia |
| Submitter's Phone Number | 605-8295 512 |
| Submitter's Fax Number | 605-8915 500 |
| Name of Contact Person | Ooi Loon Seng |
| Date of Preparation | 06 October 2011 |
| Name of Device<br>Trade Name | : MPXX™ POWDER FREE NATURAL RUBBER<br>LATEX EXAMINATION GLOVES |
| Common Name | : Latex Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency is<br>Being Claimed | MPXX™ Powder Free Natural Rubber Latex<br>Examination Gloves as described in this 510 K<br>Notification is substantially equivalent to<br>K981767, Qtexx Powder-Free Latex Examination<br>Gloves with 50 Micrograms or Less of Total<br>Water Extractable Protein Per Gram which is the<br>current Class 1 Patient Examination Glove<br>bearing the product code 80LYY ( 21 CFR<br>880.6250 ). It meets all the current specifications<br>listed under the ASTM Specification D 3578-05,<br>Standard Specification for Rubber Examination<br>Gloves. |
| | |
| Description of the Device | MPXX™™ Powder Free Natural Rubber Latex<br>Examination Gloves are substantially equivalent<br>to the Class 1 patient examination glove bearing<br>the product code 80LYY ( 21 CFR 880.6250 ). It<br>meets all the current specifications listed under<br>the ASTM Specification D-3578-05, Standard<br>Specification for Rubber Examination Gloves.<br>They are made from natural rubber latex. They<br>are natural white in color and are powder free. |
| Intended Use of the Device | MPXX™™ Powder Free Natural Rubber Latex<br>Examination Gloves are intended for single use<br>for medical purposes that is worn on the hand of<br>healthcare and similar personnel to prevent<br>contamination between healthcare personnel and<br>the patient. |
| Summary of Technological Characteristic<br>Compared to the Predicate Device | There is no different technological characteristic.<br>Gloves are made from natural rubber latex<br>compound and the initial products are low<br>powdered natural rubber latex gloves. These<br>gloves are using the existing technology, i.e.<br>multiple washing and rinsing processes. |
| Brief Description of Non-Clinical Tests | Testing were performed per ASTM D 3578-05,<br>Standard Specification for Rubber Examination<br>Gloves and 21 CFR 800.20. Gloves meet all the<br>current ASTM D 3578-05 requirements.<br>Primary skin irritation testing in the rabbit and<br>delayed contact sensitization testing in the<br>guinea pig indicate no irritation or sensitization.<br>Final product has been tested negative for the<br>presence of starch using the USP iodine test. |
| Brief description of Clinical Tests | No new clinical tests were conducted under this<br>510(k). |
| Conclusions Drawn from the Non-Clinical and<br>Clinical Tests | Non-Clinical laboratory and animal based test<br>data indicate that the powder free product meets<br>all performance and biocompatibility<br>requirements. |
| Other Information Deemed Necessary by FDA | Not Applicable. |

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| Characteristics<br>and Parameters | Subject Device<br>MPXX™ Powder Free<br>Natural Rubber Latex<br>Examination Gloves | Predicate Device<br>Qtexx Powder-Free<br>Latex Examination<br>Gloves with 50<br>Micrograms or Less of<br>Total Water<br>Extractable Protein Per<br>Gram (K981767) | Substantial<br>Equivalence<br>(SE) |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Product Code | 80LYY | 80LYY | |
| Intended Use | MPXX™ Powder Free<br>Natural Rubber Latex<br>Examination Gloves is a<br>single use device<br>intended for medical<br>purposes that is worn on<br>the hand of healthcare<br>and similar personnel to<br>prevent contamination<br>between healthcare<br>personnel and the<br>patient. | Qtexx Powder-Free<br>Latex Examination<br>Gloves with 50<br>Micrograms or Less of<br>Total Water Extractable<br>Protein Per Gram is a<br>single use device<br>intended for medical<br>purposes that is worn on<br>the hand of health care<br>and similar personnel to<br>prevent contamination<br>between the health care<br>personnel and the<br>patient. | Yes,<br>Substantial<br>Equivalence |
| Glove Thickness<br>and Length | Meets ASTM D 3578-05:<br>-Palm Thickness of ≥<br>0.08mm<br>-Finger Thickness ≥<br>0.08mm<br>-Length ≥ 240mm | Meets ASTM D 3578-95:<br>-Palm Thickness of ≥<br>0.08mm<br>-Finger Thickness ≥<br>0.08mm<br>-Length ≥ 230mm | Yes,<br>Substantial<br>Equivalence |
| Tensile Strength | Meets ASTM D 3578-05:<br>- Tensile Strength ≥<br>18MPa (≥ 18MPa per<br>Standard )<br>- Elongation ≥ 650% | Meets ASTM D 3578-95:<br>- Tensile Strength ≥<br>14MPa (≥ 14MPa per<br>Standard )<br>- Elongation ≥ 700% | Yes,<br>Substantial<br>Equivalence |
| Freedom from<br>Holes | Meets Requirements per<br>21CFR800.20:<br>Gloves Free of Holes at<br>quality level of AQL 1.5<br>(AQL 2.5 required per<br>standard) | Meets Requirements per<br>21CFR800.20:<br>Gloves Free of Holes at<br>quality level of AQL 1.5<br>(AQL 2.5 required per<br>standard) | Yes, Identical |
| Materials | Natural Rubber Latex | Natural Rubber Latex | Yes,<br>Substantial<br>Equivalence |
| Color | Natural Color | Natural Color | Yes, Identical |
| Biocompatibility | Passes:<br>- Primary Skin Irritation<br>- Dermal Sensitization | Passes:<br>- Primary Skin Irritation<br>- Dermal Sensitization | Yes, Identical |
| Powder Free | Meets Applicable<br>Definition for Powder<br>Free; ≤ 2 mg per glove | Meets Applicable<br>Definition for Powder<br>Free: ≤ 2 mg per<br>glove | Yes, Identical |
| Protein Content | Meets Applicable<br>Definition for Protein<br>Content; ≤ max 50<br>(ug/dm²) | Meets Applicable<br>Definition for Protein<br>Content; ≤ max 50<br>(ug/dm²) | Yes, Identical |
| Sterility | Not applicable: Non-<br>sterile | Not applicable: Non-<br>sterile | Yes, Identical |

### Substantial Equivalence Comparison Table

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Image /page/4/Picture/1 description: The image shows a circular seal or emblem. The seal features a stylized graphic of three curved lines, resembling a bird in flight or a flowing design. Encircling the graphic is text, which appears to be part of the seal's official designation, possibly related to a government agency or organization.

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

OCT 1 4 2011

Total Gloves. SDN BHD C/O Ms. Ooi Loon Seng Regulatory Affairs Manager Lot 2584, Jalan Perusahaan 3. Kamunting Industrial Estate Taipang City, Perak Province MALAYSIA 34600

Re: K110250

Trade/Device Name: MPXX" Powder-Free Natural Rubber Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LY Y Dated: September 12, 2011 Received: September 16, 2011

Dear Ms. Seng:

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.

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#### Page 2 - Ms. Seng

Enclosure

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (QS) 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Antimony D. Matson

Anthony B. 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

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MPXX IM Powder Free Natural Rubber Latex Examination Gloves

Attachment 2

## INDICATIONS FOR USE K110250

Applicant TOTAL GLOVE COMPANY SDN. BHD. Lot 2584, Jalan Perusahaan 3, Kamunting Industrial Estate, 34600 Kamunting , Perak, Malaysia.

510(k) Number K110250 -(if known)

Device Name

MPXX™ Powder Free Natural Rubber Latex Examination Gloves

Indications For Use

MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Eghert R.C.C. Laimins W.M.S

(Division Sign-Off) Concurrence of CDRH Office of Device Evaluation (ODE ) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110250

Prescription Use Per 21 CFR 801.109

OR Over-The-Counter