POWDER FREE LATEX EXAMINATION GLOVE

K173053 · Professional Latex Sdn Bhd · LYY · Jun 6, 2018 · General Hospital

Device Facts

• Record ID: K173053
• Device Name: POWDER FREE LATEX EXAMINATION GLOVE
• Applicant: Professional Latex Sdn Bhd
• Product Code: LYY · General Hospital
• Decision Date: Jun 6, 2018
• 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 or finger to prevent contamination between patient and examiner

Device Story

Disposable patient examination glove; natural rubber latex material; worn on examiner's hand or finger. Principle of operation: physical barrier to prevent contamination between patient and examiner. Used in clinical or medical settings; operated by healthcare professionals or individuals for over-the-counter use. Device provides protection against cross-contamination; benefits patient and examiner by reducing exposure to contaminants.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM D3578-05 for physical properties (tensile strength, elongation, dimensions, freedom from holes), residual powder, and protein levels. Biocompatibility testing performed per ISO 10993-10 (irritation, sensitization) and ISO 10993-5 (cytotoxicity).

Technological Characteristics

Natural rubber latex; non-sterile; powder-free. Dimensions and physical properties comply with ASTM D3578-05. Biocompatibility: ISO 10993-10 (skin irritation, dermal sensitization) and ISO 10993-5 (cytotoxicity).

Indications for Use

Indicated for use as a disposable medical device worn on the examiner's 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.

Predicate Devices

• LATEX EXAMINATION GLOVES POWDER FREE (K161833)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 6, 2018

Professional Latex Sdn Bhd Terence Lim Regulatory Affairs Manager Lot 52, Jalan Logam 2, Kamunting Raya Industrial Kamunting, Perak 34600 Malaysia

Re: K173053

Trade/Device Name: Powder Free Latex Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYY Dated: April 30, 2018 Received: May 7, 2018

Dear Terence Lim:

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.

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 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);

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## Page 2 - Terence Lim

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S for 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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# Indications for Use

510(k) Number (if known) K173053

Device Name Powder Free Latex Examination Glove

Indications for Use (Describe)

A 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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### Professional Latex Sdn Bhd

Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak

### 510 (K) SUMMARY

| 1.0 | Submitter | Professional Latex Sdn Bhd<br>Lot 52, Jalan Logam 2, Kamunting Raya Industrial<br>34600 Kamunting, Perak |
|-----|---------------------------|----------------------------------------------------------------------------------------------------------|
| | Tel: | +605 - 891 1637 |
| | Fax: | +605 - 891 1417 |
| | Name of Contact Person: | Terence Lim |
| | Email Address: | Terencelim @professionallatex.com |
| | Date of Summary Prepared: | May 31, 2018 |

#### 2.0 Name of Device:

| 510k no. | K173053 |
|------------------------|--------------------------------------|
| Trade Name: | Powder Free Latex Examination Glove |
| Classification Name: | Non-Powder Patient Examination Glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital |
| Product Code: | LYY |

#### 3.0 Identification of The Legally Marketed Device

Predicate Device Name: LATEX EXAMINATION GLOVES POWDER FREE

Predicate 510(K) Number: K161833

Manufacturer's Name: CAREGLOVE GLOBAL SDN BHD

#### 4.0 Description of Device

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

#### 5.0 The Intended Use of Glove

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

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Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak

### Summary of the Technological Characteristic of the Device compared to the Predicate Device 6.0 for Substantial Equivalent Discussion.

There is no difference in technology characteristic compared to the predicate device. Gloves are made from natural rubber latex compound. Non-Sterile, Powder Free Latex Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.

| Characteristics<br>and Parameters | Powder Free Latex<br>Examination Glove<br>(K173053) | Powder Free Latex<br>Examination Glove<br>(K161833) | Comparison |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Product Code | LYY | LYY | Same product Code |
| Intended Use | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | Same Intended Use.<br>Meeting 21 CFR<br>880.6250<br>requirement. |
| Classification | Class 1 | Class 1: | Same. |
| Raw Rubber<br>Material | Natural Rubber Latex | Natural Rubber Latex | Same base material. |
| Colour | No colour pigment<br>added. Natural White | No colour pigment<br>added.Natural White | Similar. |
| Overall Length<br>Minimum 230mm | Average: 242 mm | Meet ASTM D3578-05 | Similar.<br>Meeting requirement<br>of length under ASTM<br>D 3578-05 |
| Width | Average:<br>S: 85 mm<br>M: 95mm<br>L:104mm: | S: 82mm – 87 mm<br>M: 94mm – 97 mm<br>L: 102mm – 107mm | Similar.<br>Meeting requirement<br>of Width under ASTM<br>D 3578-05 |
| Palm Thickness<br>(Minimum 0.08mm) | Average:<br>0.09mm | 0.12mm - 0.14 mm | Similar.<br>Meeting requirement<br>of Palm thickness<br>under ASTM D 3578-<br>05 |
| Finger Thickness<br>(Minimum 0.08mm) | Average:<br>0.11 mm | 0.10 - 0.13 mm | Similar.<br>Meeting requirement<br>of Palm thickness<br>under ASTM D 3578-<br>05 |
| Characteristics and<br>Parameters | Powder Free Latex<br>Examination Glove<br>(K173053) | Powder Free Latex<br>Examination Glove<br>(K161833) | Comparison |
| Tensile Strength<br>(before age)<br>Minimum 18 MPa | Average: 23.65 MPa | 21.18 – 26.17 MPa | Similar.<br>Meeting requirement<br>of Tensile Strength<br>under ASTM D 3578-<br>05 |
| Tensile Strength<br>(After Age)<br>Minimum 14 MPa | Average: 20.99 MPa | 18.28 – 23.88 MPa | Similar.<br>Meeting requirement<br>of Tensile Strength<br>under ASTM D 3578-<br>05 |
| Stress at 500%<br>Elongation<br>5.5 MPa Maximum | 3.5 MPa | 3.0 – 4.2 MPa | Similar.<br>Meeting requirement<br>of Tensile Strength<br>under ASTM D 3578-<br>05 |
| Ultimate Elongation<br>before age<br>(Minimum 500%) | Average: 734% | 750.20% - 820.20% | Similar.<br>Meeting requirement<br>of Tensile Strength<br>under ASTM D 3578-<br>05 |
| Elongation<br>Ultimate<br>after age<br>(Minimum 400%) | Average: 622% | 550.40% - 700.50% | Similar.<br>Meeting requirement<br>of Tensile Strength<br>under ASTM D 3578-<br>05 |
| Freedom of Holes<br>Meet AQL 2.5 at G1 | Meet AQL 2.5 with G1 | Meet AQL 2.5 with<br>G1. | Similar.<br>Meeting requirements<br>of Freedom of Holes<br>under ASTM D 3578-<br>05 |
| Residual powder test<br>(Less than<br>2mg/glove) | Average powder<br>residue for each size:<br>S: 0.43 mg/glove<br>M 0.31 mg/glove<br>L 0.47 mg/glove | Contained less than<br>2mg/glove | Similar.<br>Meeting requirement<br>of powder residue<br>under ASTM D 3578-<br>05 |
| Protein Testing | S size: Less than 50<br>µg/dm²<br>M size: Less than 50<br>µg/dm²<br>L size: Less than 50<br>µg/dm² | less than 50 µg/dm² | Similar.<br>Meeting requirement<br>of protein level under<br>ASTM D 3578-05 |
| Primary Skin<br>Irritation | Under the conditions<br>of study, not an<br>irritant | Under the conditions<br>of study, not an<br>irritant | Same.<br>Both are tested to be<br>non-irritant. Under<br>ISO 10993 -10 |
| Dermal Sensitization | Under the conditions<br>of study, not a<br>sensitizer. | Under the conditions<br>of study, not a<br>sensitizer. | Same.<br>Both are tested to be<br>non-sensitizer. |
| | | | Under ISO 10993-10 |
| Cytotoxicity | Under the condition of<br>the study, the extract<br>from the device is<br>non- cytotoxic to L-<br>929 cells | Not available | The subject device<br>extract is non-<br>cytotoxic to L-929<br>cells under ISO<br>10993-5 |

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# Professional Latex Sdn Bhd

Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak

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### Professional Latex Sdn Bhd

Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600 Kamunting, Perak

#### 7.0 Non-Clinical Performance Data

The performance test data of the non-clinical tests is reported in the table above.

#### 8.0 Assessment of Clinical Performance Data

Not applicable - Clinical data is not needed.

#### 9.0 Conclusion

From the non-clinical tests, it can be concluded that the Powder Free Latex Examination Glove, Non-Sterile, is as safe and as effective and performs as well or better than the legally marketed preeicate device.