A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

K153744 · A1 Glove Sdn Bhd · LYY · Aug 4, 2016 · General Hospital

Device Facts

• Record ID: K153744
• Device Name: A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
• Applicant: A1 Glove Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Aug 4, 2016
• 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.

Device Story

Disposable natural rubber latex patient examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Device functions as a physical barrier. Performance verified through bench testing against ASTM standards for dimensions, physical properties, pin-hole resistance, powder residue, and protein content. Biocompatibility confirmed via ISO 10993-10 testing for irritation and sensitization.

Clinical Evidence

No clinical data; substantial equivalence supported by non-clinical bench testing including physical properties, pin-hole testing, protein content analysis, and biocompatibility (ISO 10993-10).

Technological Characteristics

Natural rubber latex; powder-free. Dimensions: palm/finger thickness min 0.08mm; length 220-240mm. Physical properties: tensile strength min 18 MPa (before aging), 14 MPa (after); elongation min 650% (before), 500% (after). Protein content <50ug/dm². Standards: ASTM D3578:05-2010, ASTM D412:06, ASTM D573:04-2010, ASTM D5151:06-2011, ASTM D6124:06-2011, ASTM D5712:10-2010, ISO 10993-10:2010.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent 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.

Predicate Devices

• Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (K112612)

Submission Summary (Full Text)

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

September 6, 2016

A1 Glove Sdn. Bhd. Mr. John Phan Lot 3726, Kawasan Perindustrian Nilai, Mukim Setul Nilai. Negeri Sembilan 71900 MALAYSIA

Re: K153744

Trade/Device Name: A1 Brand Powder Free Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYY Dated: July 13, 2016 Received: July 13, 2016

Dear: John Phan

This letter corrects our substantially equivalent letter of July 13, 2016.

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 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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K 153744

#### Device Name

A 1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contain 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

#### Indications for Use (Describe)

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.

pe of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) Summary

### A1 GLOVE SDN. BHD.

## Date: 8th July 2016

## 510k number: K 153744

### 1.01 Submitter:

| Name | : A1 Glove Sdn. Bhd. |
|-----------|------------------------------------------------------------------------------------|
| Address | : Lot 3726, Kawasan Perindustrian Nilai,<br>Mukim Setul, Daerah Seremban, Malaysia |
| Country | : Malaysia |
| Phone No. | : [phone] |

### 1.02 Contact Person:

| Contact | : Mr. John Phan |
|---------------|-------------------------|
| E-mail | : [e-mail] |
| Telephone No. | : [phone] |
| Fax No. | : [phone] |

### 1.03 Name of Device:

| Trade Name | : A1 Glove Powder Free Latex Patient Examination Gloves with |
|---------------------|--------------------------------------------------------------|
| | Protein Content Labeling Claim (Contain 50 Micrograms |
| | per dm² of glove or Less of Water Extractable Protein) |
| Common Name | : Patient Examination Gloves |
| Classification Name | : Patient Examination Glove |
| Product Code | : LYY |

#### 1.04 Identification of The Legally Marketed Device:

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contain 50 Micrograms per dm of Glove or Less of Water Extractable Protein), LYY, meets all of the requirements of ASTM D-3578 Standard Specification of Latex Examination Gloves for Medical Application which equivalent to legally marketed device of K112612.

Predicate Device: K112612, Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein)

#### 1.05 Description of Device

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578:05-2010

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### 1.06 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.

### 1.07 Summary of the Technological Characteristics of the Device

Powder Free Latex Examination Gloves possesses the following technological characteristic (as compared to ASTM or equivalent standard):

| CHARACTERISTICS | STANDARDS | SPECIFICATION | DEVICE PERFORMANCE/<br>ACTUAL SPECIFICATION |
|------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Dimensions | ASTM D3578:05-2010 | Thickness<br>Palm : min 0.08mm<br>Finger: min 0.08mm | Meet.<br>Palm Thickness: 0.09 mm<br>Finger Thickness: 0.11 mm |
| | | Length (by size)<br>S : min 220<br>M : min 220<br>L : min 230 | Length (by size)<br>S : 240 mm<br>M : 240 mm<br>L : 240 mm |
| Physical Properties | ASTM D3578:05-2010<br>ASTM D412:06<br>ASTM D573:04-2010 | Tensile Strength (MPa)<br>Before aging : Min 18 MPa<br>After aging : Min 14 MPa | Meet<br>Tensile Strength (MPa)<br>Before aging : 22.91 MPa<br>After Aging : 20.98 MPa |
| | | Elongation at Break (%)<br>Before aging : Min 650mm<br>After aging: Min 500mm | Elongation at Break (%)<br>Before aging : 850 mm<br>After aging : 820 mm |
| Freedom from pin-holes | ASTM D5151:06-2011 | AQL 1.5 | Meet |
| Powder Free Residue | ASTM D6124:06-2011 | Below 2mg/glove | Meet |
| Protein Content | ASTM D5712:10-2010 | Below 50ug/dm² | Meet |
| Biocompatibility | Animal Irritation Test<br>(ISO 10993-10:2010) | Under the conditions<br>tested, the subject glove<br>was not an irritant. | Under the conditions tested, the<br>subject glove was not an<br>irritant. |
| | Dermal Sensitization<br>(ISO 10993-10:2010) | Under the condition tested,<br>the subject glove was not a<br>sensitizer. | Under the condition tested, the<br>subject glove was not a<br>sensitizer. |

1.08 Substantial Equivalent based on Assessment of Non-Clinical Performance Data The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as shown on the table above.

1.09 Substantial Equivalent based on Assessment of Clinical Performance Data Clinical data for the subject glove is not needed.

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| 1.10 Substantial Equivalence Comparison | | | | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Characteristic &<br>Parameters | Predicate Device | Proposed Device | Specification | Substantial<br>Equivalence |
| | K112612, Powder Free Latex<br>Patient Examination Glove<br>with Protein Content Labeling<br>Claim (Contains 50<br>Micrograms per dm² of glove<br>or Less of Water Extractable<br>Protein) | A1 Glove Powder Free Latex<br>Patient Examination Gloves<br>with Protein Content Labeling<br>Claim (Contain 50 Micrograms<br>per dm² of glove or Less of<br>Water Extractable Protein) | | SE |
| Product Code | LYY | LYY | | SE |
| FDA Device Class | Class I | Class I | | SE |
| Intended Use | A patient examination gloves is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand to<br>prevent contamination between<br>patient and examiner. | | SE |
| Material | Natural Rubber Latex | Natural Rubber Latex | | SE |
| Dimensions | Meets ASTM D3578 | Meets ASTM D3578:05-2010 | Thickness<br>Palm : min 0.08mm<br>Finger : min 0.08mm<br><br>Length (by size)<br>S : min 220<br>M : min 220<br>L : min 230 | SE |
| Physical Properties | Meets ASTM D3578 | Meets ASTM D3578:05-2010 | Tensile Strength (MPa)<br>Before aging : Min 18 MPa<br>After aging : Min 14 MPa<br><br>Elongation at Break (%)<br>Before aging : Min 650mm<br>After aging: Min 500mm | SE |
| Freedom from Pin Holes -<br>ASTM D5151 | Meets ASTM D5151 | Meets ASTM D5151:06:2011 | AQL 1.5 | SE |
| Protein Content-<br>ASTM D5712 | Meets ASTM D5712 | Meets ASTM D5712:10-2010 | Below 50ug/dm² | SE |
| Skin Irritation<br>ISO 10993-10:2002 | Under the condition tested, the<br>subject glove was not an<br>irritant. | Under the condition tested, the<br>subject glove was not an<br>irritant. | Under the condition tested,<br>the subject glove was not an<br>irritant. | SE |
| Dermal sensitization<br>ISO 10993-10:2002 | Under the condition tested, the<br>subject glove was not a<br>sensitizer. | Under the condition tested, the<br>subject glove was not a<br>sensitizer. | Under the condition tested,<br>the subject glove was not a<br>sensitizer. | SE |

# 1.10 Substantial Equivalence Comparison

Table 1.10. Substantial Equivalence Comparison

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# 1.11 Conclusion

The conclusion drawn from the non-clinical testing demonstrates that the subject glove is as safe, as effective, and performs as well as the legally marketed predicate device, K112612.