ComfortPro Blue Nitrile Examination Gloves Powder Free

K212850 · Thai Rubber Industry Company Limited · LZA · Dec 10, 2021 · General Hospital

Device Facts

• Record ID: K212850
• Device Name: ComfortPro Blue Nitrile Examination Gloves Powder Free
• Applicant: Thai Rubber Industry Company Limited
• Product Code: LZA · General Hospital
• Decision Date: Dec 10, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile (NBR) examination gloves; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner. Used in clinical or medical settings. Non-sterile, powder-free, ambidextrous design. Available in sizes XS to XL. Provides physical barrier; protects both patient and clinician during examinations.

Clinical Evidence

No clinical data. Bench testing only, including physical property testing (tensile strength, elongation), water-tightness (ASTM D5151-19), residual powder (ASTM D6124-06), and biocompatibility (ISO 10993-5, 10, 11).

Technological Characteristics

Material: 100% Nitrile (NBR). Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06. Biocompatibility: ISO 10993-5, 10, 11. Form factor: Ambidextrous, powder-free, non-sterile. Sizes: XS, S, M, L, XL.

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

• Palm Care Blue Nitrile Examination Gloves (K202384)

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.

December 10, 2021

Thai Rubber Industry Company Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504

Re: K212850

Trade/Device Name: ComfortPro Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 13, 2021 Received: September 7, 2021

Dear Manoj Zacharias:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212850

#### Device Name

ComfortPro Blue Nitrile Examination Gloves Powder free

Indications for Use (Describe)

ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

| <input type="checkbox"/> | Commercial |
|--------------------------|-------------|
| <input type="checkbox"/> | Residential |

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K212850 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)

## A. APPLICANT INFORMATION

| 510(K) Owner's Name | THAI RUBBER INDUSTRY COMPANY LIMITED |
|---------------------|--------------------------------------------------------------|
| Address | 738 MOO 5, MANAM KOO,<br>PLUAKDAENG<br>RAYONG 21140 THAILAND |
| Phone | [phone] |
| Fax | - |
| E-mail | [e-mail] |
| Contact Person | Ms. Supawadee Phoungthong |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date Submitted | December 9, 2021 |

### B. DEVICE IDENTIFICATION

| Name of the device | ComfortPro Blue Nitrile Examination Gloves<br>Powder Free |
|-----------------------------------|-----------------------------------------------------------|
| Product proprietary or trade name | ComfortPro |
| Common or usual name | Nitrile Examination Gloves |
| Classification name | Polymer Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

### C. PREDICATE DEVICE

| Predicate Device | Hi-Care Thai Gloves Co. Ltd. |
|------------------|------------------------------|
| 510(k) Number | K202384 |
| Regulatory Class | Class 1 |
| Product code | LZA |

### D. DESCRIPTION OF THE DEVICE:

ComfortPro Blue Nitrile Examination Gloves Powder Free is Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from Nitrile (NBR)100%. These gloves are blue in color, non-sterile, ambidextrous, powder free and single use only. Blue Nitrile Examination Gloves Powder Free are available in sizes X-small, Small, Medium, Large and X Large.

### E. INDICATION FOR USE OF THE DEVICE:

ComfortPro Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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# 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)

## F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | | REMARKS |
|--------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------|
| | | PREDICATE | SUBJECT | | |
| 510(K) Number | | K202384 | K212850 | | |
| Name of device | -- | Palm Care Blue Nitrile | ComfortPro Blue Nitrile | | |
| | | Examination Gloves | Examination Gloves | | ---- |
| | | Powder free | Powder Free | | |
| Dimensions- Length | ASTMD 6319-19 | Length Min 230 mm | Length > 230 mm | | Similar |
| | | | Size | Average | |
| | | | X-Small | 250 | |
| | | | Small | 241 | |
| | | | Medium | 245 | |
| | | | Large | 242 | |
| | | | X- Large | 242 | |
| Dimensions- Width | ASTMD 6319-19 | Width Min 95+/-10mm | Width Min 95+/-10mm | | Similar |
| | | (for medium size) | (for medium size) | | |
| | | | Size | Average | |
| | | | X-Small | 80 | |
| | | | Small | 82 | |
| | | | Medium | 93 | |
| | | | Large | 103 | |
| | | | X- Large | 110 | |
| Physical Properties- | ASTMD 6319-19 | Before Ageing | Before Ageing | | |
| Tensile Strength | | Tensile Strength | Tensile Strength > | | |
| | | min 14 Mpa<br>After Ageing | 14 Mpa<br>Size | Average | |
| | | Tensile Strength | | | Similar |
| | | min 14 Mpa | X-Small | 27.2 | |
| | | | Small<br>Medium | 23.2 | |
| | | | | 24 | |
| | | | Large | 26.2 | |
| | | | X- Large | 27.4 | |
| | | | | After Ageing | |
| | | | Tensile Strength > | | |
| | | | 14 Mpa | | |
| | | | Size | Average | |
| | | | X-Small<br>Small | 24.2<br>23.8 | |
| | | | Medium | 27.6 | |
| | | | Large | 27.6 | |
| | | | X- Large | 27.9 | |
| Physical Properties- | ASTMD 6319-19 | Before Ageing | | | Similar |
| Ultimate Elongation | | Ultimate Elongation | Before Ageing<br>Ultimate Elongation ><br>500% | | |
| | | > 500% | | | |
| | | | X-Small | 620 | |
| | | | Small | 290 | |
| | | | Medium | 570 | |
| | | | Large | 570 | |
| | | | X- Large | રરા | |
| | | | | | |
| | | | | | |
| | | | | | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS | |
| | | PREDICATE | SUBJECT | | |
| | ASTMD 6319-19 | After Ageing<br>Ultimate<br>Elongation >400% | After Ageing<br>Ultimate Elongation > 400%<br>X-Small 600<br>Small 560<br>Medium 540<br>Large 540<br>X- Large 550 | Similar | |
| Thickness | ASTMD 6319-19 | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm > 0.05 mm Finger > 0.05 mm<br>Size Palm (Actual value) mm Finger (Actual value) mm<br>X-Small 0.101 0.121<br>Small 0.081 0.097<br>Medium 0.091 0.108<br>Large 0.092 0.108<br>X- Large 0.091 0.111 | Similar | |
| Powder Residue | ASTMD 6319-19 | <2 mg/glove | <2 mg/glove<br>Actual value :0.49 mg/glove | Similar | |
| Biocompatibility | Primary Skin Irritation-<br>ISO 10993-10:2010(E) | Under the<br>condition of study<br>not an irritant | Under the condition of study not<br>an irritant | Same | |
| | Dermal Sensitization-<br>ISO 10993-<br>10:2010(E) | Under the conditions<br>of the study not a<br>sensitizer | Under the conditions of the<br>study not a sensitizer | Same | |
| | In vitro cytotoxicity<br>ISO10993-5 2009(E) | Under the conditions<br>of the study,<br>noncytotoxic | Under the conditions of the study<br>cytotoxic for 100% test item extract<br>and non-cytotoxic at 50%, 25%,<br>12.5% and 6.25% test item extracts.<br>Moreover, under the conditions of<br>the study, non acute systemic toxic. | Similar | |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the<br>conditions of study,<br>the device extracts<br>do not pose a<br>systemic toxicity<br>concern. | Under the condition of study, the<br>device extracts did not reveal any<br>systemic toxicity. | Same | |
| Water Tight<br>(1000 ml) | ASTM D 5151-19<br>AQL 2.5 | Passes | Passes | Similar | |
| Indication for Use | -- | Blue Nitrile<br>Examination Gloves<br>Powder Free is<br>disposable devices<br>intended for medical<br>purpose that are<br>worn on the<br>examiner's hand to<br>prevent contaminatio<br>between patient and<br>examiner. | ComfortPro Blue Nitrile<br>Examination Gloves Powder<br>Free is disposable device<br>intended for medical purpose<br>that is worn on the examiner's<br>hand to prevent contamination<br>between patient and examiner. | Similar | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS | |
| | | PREDICATE | SUBJECT | | |
| Material | ASTMD 6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same | |
| Color | -- | Blue | Blue | Same | |
| Size | ASTMD 6319-19 | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Same | |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same | |
| Sterile/non sterile | -- | Nonsterile | Nonsterile | Same | |
| Powder/Powder free | -- | Powder free | Powder free | Same | |
| Label and Labeling | Meets FDA's label<br>and labeling<br>requirements | Meets FDA's label and<br>labeling requirements | Meets FDA's label and<br>labeling requirements | Same | |
| Manufacturer(s) | -- | Hi-Care Thai Gloves Co.<br>Ltd. Thailand. | THAI RUBBER<br>INDUSTRY CO., LTD.. | ----- | |

Page 2 of 6

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# 510(K) SUMMARY
AS REQUIRED BY: 21CFR§807.92(C)

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# 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D 6319-19.

# G. COMPARISON BASED ON ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA

## BENCH TEST DATA

| TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT |
|-------------------------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| ASTM D6319-19<br>Standard Specification for nitrile<br>examination gloves for medical<br>Application. | To determine the<br>length of the gloves | Min 230 mm for all<br>sizes | X-Small: 250mm<br>Small:- 241mm<br>Medium: - 245 mm<br>Large:- 242 mm<br>X-Large- 242 mm |
| ASTM D6319-19<br>Standard Specification for nitrile<br>examination gloves for medical<br>Application. | To determine the<br>width of the gloves | X-Small:-70+/-10 mm<br>Small:-80+/-10mm<br>Medium:-95+/-10 mm<br>Large:-110+/-10 mm<br>X Large:- 120+/-10 mm | X-Small:- 80 mm<br>Small:- 82mm<br>Medium:-93mm<br>Large:- 103mm<br>X-Large-110mm |

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# 510(K) SUMMARY AS REQUIRED BY: 21CFR§807.92(C)

| TEST<br>METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT | | |
|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------|---------------------|
| ASTM D6319-19<br>Standard<br>Specification for<br>nitrile examination<br>gloves for medical<br>Application. | To determine the<br>thickness of the<br>gloves | Palm<br>0.05 mm min<br>Finger<br>0.05 mm min<br>for all sizes | Size | Palm | Finger |
| | | | X-Small | 0.101 mm | 0.121 mm |
| | | | Small | 0.081mm | 0.097mm |
| | | | Medium | 0.091 mm | 0.108mm |
| | | | Large | 0.092mm | 0.108mm |
| | | | X Large | 0.091 mm | 0.111mm |
| ASTM D6319-19<br>Standard<br>Specification for<br>nitrile examination<br>gloves for medical<br>Application. | To Determine the<br>physical properties-<br>Tensile strength | <b>Before Ageing</b><br>Tensile Strength 14<br>Mpa Min for all<br>sizes<br><b>After Ageing</b><br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size | <b>Before ageing</b> | <b>After ageing</b> |
| | | | X-Small | 27.2 Mpa | 24.2 Mpa |
| | | | Small | 23.2 Mpa | 23.8 Mpa |
| | | | Medium | 24 Mpa | 27.6 Mpa |
| | | | Large | 26.2 Mpa | 27.6 Mpa |
| | | | X Large | 27.4 Mpa | 27.9 Mpa |
| | To Determine the<br>physical properties-<br>Ultimate Elongation | <b>Before Ageing</b><br>Ultimate<br>Elongation<br>500% Min for all<br>sizes<br><b>After Ageing</b><br>Ultimate<br>Elongation 400%<br>Min for all sizes | Size | <b>Before ageing</b> | <b>After ageing</b> |
| | | | X-Small | 620% | 600% |
| | | | Small | 590% | 560% |
| | | | Medium | 570% | 540% |
| | | | Large | 570% | 540% |
| | | | X Large | 550% | 550% |
| ASTMD 5151-19<br>Standard Test<br>Method for<br>Detection of<br>Holes in Medical<br>Gloves | To determine the<br>holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 | | |
| ASTM D6124-06<br>(Reapproved<br>2017) Standard<br>Test Method for<br>Residual Powder<br>on Medical<br>Gloves | To determine the<br>residual powder in<br>the gloves | ≤2 Mg/Glove | 0.49 mg/glove | | |

# BIOCOMPATIBILITY DATA

| TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|
| ISO 10993-10:2010( E)<br>Biological Evaluation Of<br>Medical Devices - Part 10:<br>Tests For Irritation And Skin<br>Sensitization.<br>Test done for irritation. | To evaluate the test item,<br>for skin irritation test in<br>New Zealand White<br>rabbits. | Under the condition<br>of study not an<br>irritant | Under the condition of<br>study, not an irritant |

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# 510(K) SUMMARY AS REQUIRED BY: 21CFR8807.92(C)

| TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993 10:2010(E)<br>Biological Evaluation of<br>Medical Devices - Part 10:<br>Tests for Irritation and Skin<br>Sensitization.<br>Test done for skin sensitization | To evaluate the test item,<br>for the Skin Sensitization<br>in Guinea pigs by<br>maximization test. | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions of the<br>study, not a sensitizer |
| ISO10993-5:2009(E)<br>Biological evaluation of<br>medical devices - part 5, tests<br>for In vitro cytotoxicity. | To evaluate the test item,<br>for its ability to induce<br>cytotoxicity using L-929<br>mouse fibroblast cells by<br>Elution Method. | Under the conditions<br>of the study, non-<br>cytotoxic | Under the conditions of the<br>study cytotoxic for 100% test<br>item extract and non-<br>cytotoxic at 50%, 25%,<br>12.5% and 6.25% test item<br>extracts. Moreover, under the<br>conditions of the study, non<br>acute systemic toxic. |
| ISO 10993-11:2017(E)<br>Biological evaluation of<br>medical devices - part 11, tests<br>for systemic toxicity. | To evaluate the test item,<br>for Acute Systemic<br>Toxicity in Swiss Albino<br>Mice. | Under the conditions<br>of study, the device<br>extracts do not pose<br>a systemic toxicity<br>concern | Under the condition of<br>study, the device extracts<br>did not reveal any<br>systemic toxicity. |

The performance test data of the non-clinical tests demonstrates that the subject device meet the acceptance criteria and the specifications found in the standards and test methodology.

The performance test data of the non-clinical tests meet following standards:

ASTMD 6319-19 Standard Specification for Nitrile examination gloves for medical Application.

ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves

ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

ISO 10993-5:2009 (E) Biological evaluation of medical devices - part 5, tests for In vitro cytotoxicity.

ISO 10993-11:2017(E) biological evaluation of medical devices - part 11, tests for systemic toxicity.

#### H. COMPARISON BASED ON ASSESSMENT OF CLINICAL PERFORMANCE DATA

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

#### I. CONCLUSION

The conclusions drawn from the non-clinical tests demonstrate that the subject device in 510(K) submission, ComfortPro Blue Nitrile Examination Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384.