Goody Gloves, Wincare, TBG Gloves

K213073 · Thai Rubber Gloves Co., Ltd. · LYY · Dec 29, 2021 · General Hospital

Device Facts

• Record ID: K213073
• Device Name: Goody Gloves, Wincare, TBG Gloves
• Applicant: Thai Rubber Gloves Co., Ltd.
• Product Code: LYY · General Hospital
• Decision Date: Dec 29, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable, non-sterile, ambidextrous natural rubber latex examination gloves; powder-free. Worn by clinicians on hands to provide barrier protection against cross-contamination between patient and examiner. Manufactured to meet ASTM D3578-19 specifications. Available in sizes X-Small through X-Large. Used in clinical settings; no specialized operation required.

Clinical Evidence

Bench testing only. Performance verified against ASTM D3578-19 (dimensions, physical properties), ASTM D5151-19 (watertightness/holes), ASTM D6124-06 (residual powder), and ASTM D5712-15 (extractable protein). Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Natural rubber latex. Form factor: Ambidextrous, powder-free, non-sterile gloves. Standards: ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15. Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-11. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for use by clinicians in medical settings.

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

• Hi-Care Thai Gloves Co. Ltd. (K202377)

Reference Devices

• JR Engineering & Medical Technologies (M) SDN.BHD. (K192329)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 29, 2021

Thai Rubber Gloves Co., Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114. Aurora, Illinois 60504, USA

Re: K213073

Trade/Device Name: Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Latex Exmamination Powder Free Gloves Regulatory Class: Class I. reserved Product Code: LYY Dated: November 30, 2021 Received: November 30, 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.

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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) 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.

For Clarence Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K213073

Device Name Latex Examination Powder Free Gloves

Indications for Use (Describe)

Latex Examination Powder Free Gloves are disposable devices 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(K) SUMMARY K213073

### AS REQUIRED BY: 21CFR§807.92

### A. APPLICANT INFORMATION

| 510(K) Owner's Name | THAI RUBBER GLOVES CO., LTD. |
|---------------------|-------------------------------------------------------------------------|
| Address | 680 MOO 2 BANBUENG – KLAENG<br>RD., NONGYAI CHONBURI 20190<br>THAILAND. |
| Phone | [phone], [phone] |
| Fax | [phone] |
| E-mail | [e-mail]<br>[e-mail] |
| Contact Person | Miss Chalongkwan Wongsasuthikul |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date Submitted | 29 December 2021 |

### B. DEVICE IDENTIFICATION

| Name of the device | Latex Examination Powder Free Gloves |
|-----------------------------------|--------------------------------------|
| Product proprietary or trade name | Goody Gloves / Wincare / TBG Gloves |
| Common or usual name | Latex examination powder free gloves |
| Classification name | Latex Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

### C. PREDICATE DEVICE

| Predicate Device | Hi-Care Thai Gloves Co. Ltd. |
|------------------|------------------------------|
| 510(k) Number | K202377 |
| Regulatory Class | Class 1 |
| Product code | LYY |

| Reference Device | JR Engineering & Medical Technologies (M)<br>SDN.BHD. |
|------------------|-------------------------------------------------------|
| 510(k) Number | K192329 |
| Regulatory Class | Class 1 |
| Product code | LYY |

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### D. DESCRIPTION OF THE DEVICE:

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are Natural in color (No color added) and are powder free, non-sterile, ambidextrous and single use only.

Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.

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

Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison | | | | | | | | | | | | |
|---------------------------------------------|---------------|---------------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|---------|
| | | PREDICATE | REFERENCE | SUBJECT | | | | | | | | | | | | | |
| 510(k) Number | --- | K202377 | K192329 | K213073 | --- | | | | | | | | | | | | |
| Name of device | --- | Palm Care Latex<br>Examination<br>Powder Free<br>Gloves | Blue Latex<br>Examination<br>Powder Free<br>Gloves | Latex Examination<br>Powder Free Gloves | --- | | | | | | | | | | | | |
| Dimensions- Length | ASTM D3578-19 | Length > 230 mm | Length > 230 mm | Length > 230 mm<br>Size Average X-Small 245 Small 244 Medium 247 Large 240 X-Large 247 | | | | | | | | | | | | | Similar |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison | | | | | | | | | | | | |
| | | PREDICATE | REFERENCE | SUBJECT | | | | | | | | | | | | | |
| 510(k) Number | | K202377 | K192329 | K213073 | | | | | | | | | | | | | |
| Physical Properties-<br>Tensile Strength | ASTM D3578-19 | Before<br>Ageing<br>Tensile<br>Strength<br>> 18 MPa | Before<br>Ageing<br>Tensile<br>Strength<br>> 18 MPa | Before Ageing<br>Tensile Strength<br>> 18 MPa | Similar | | | | | | | | | | | | |
| | | | | Size Ac tual<br>value X-Small 26.2 Small 25.0 Medium 24.0 Large 22.6 X-Large 24.2 | | | | | | | | | | | | | |
| Dimensions- Width | ASTM D3578-19 | Width Min<br>95+/- 10 mm<br>(for medium<br>size) | Width Min<br>95+/- 10 mm<br>(for medium<br>size) | Width 95+/-10 mm<br>(for medium size)<br>Size Average X-Small 77 Small 80 Medium 92 Large 101 X-Large 110 | | | | | | | | | | | | | Similar |
| | | After Ageing<br>Tensile<br>Strength<br>> 14 MPa | After Ageing<br>Tensile<br>Strength<br>> 14 MPa | After Ageing<br>Tensile Strength<br>> 14 MPa | Similar | | | | | | | | | | | | |
| | | | | Size Actual<br>value X-Small 24.1 Small 24.1 Medium 23.4 Large 24.3 X-Large 22.5 | | | | | | | | | | | | | |
| Physical Properties-<br>Ultimate Elongation | ASTM D3578-19 | Before<br>Ageing<br>Ultimate<br>Elongation<br>> 650% | Before<br>A geing<br>Ultimate<br>Elongation<br>> 650% | Before Ageing<br>Ultimate Elongation<br>> 650% | Similar | | | | | | | | | | | | |
| | | | | Size Actual<br>value X-Small 830 Small 790 Medium 810 Large 800 X-Large 800 | | | | | | | | | | | | | |
| | | After<br>Ageing<br>Ultimate<br>Elongation<br>>500% | After A<br>geing<br>Ultimate<br>Elongation<br>>500% | After Ageing<br>Ultimate Elongation<br>> 500% | Similar | | | | | | | | | | | | |
| | | | | Size Actual<br>value X-Small 800 Small 760 Medium 830 Large 810 X-Large 780 | | | | | | | | | | | | | |

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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison | | | | | | | | | | | | | | | | | | |
|---------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--|--|--|--|--|--|--|--|--|--|--|---------|--|--|--|--|--|---------|
| | | PREDICATE<br>K202377 | REFERENCE<br>K192329 | SUBJECT<br>K213073 | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | | | | | | | | | | | | | | | | | | | | | | | |
| Thickness | ASTM D3578-19 | Palm > 0.08 mm<br>Finger > 0.08 mm | Palm > 0.08 mm<br>Finger > 0.08 mm | Palm > 0.08 mm<br>Finger > 0.08 mm<br><br>Size Palm (Actual value) Finger (Actual value) X-Small 0.115 0.125 Small 0.115 0.128 Medium 0.115 0.132 Large 0.121 0.135 X-Large 0.109 0.122 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Free Residue | ASTM D3578-19 | ≤2 mg/glove | ≤2 mg/glove | ≤2 mg/glove<br>Size Actual value X-Small 0.60 Small 0.80 Medium 1.46 Large 0.62 X-Large 1.13 | | | | | | | | | | | | | Similar | | | | | | |
| Biocompatibility | Primary Skin<br>Irritation-ISO<br>10993-10:2010(E) | Under the condition of<br>study, not an<br>irritant | Under the condition of<br>study, not an<br>irritant | Under the condition of<br>study, not an irritant | Same | | | | | | | | | | | | | | | | | | |
| | Dermal<br>Sensitization-ISO<br>10993-10:2010(E) | Under the<br>conditions of<br>the study, not a<br>sensitizer | Under the<br>conditions of<br>the study, not a<br>sensitizer | Under the conditions of<br>the study, not a sensitizer | Same | | | | | | | | | | | | | | | | | | |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the<br>conditions<br>of the study,<br>non-cytotoxic | Under the<br>conditions of<br>the study,<br>cytotoxic<br>which is to be<br>expected as<br>latex is the<br>positive<br>control for this<br>test. | Under the conditions of<br>the study, cytotoxic | Similar to<br>reference<br>device | | | | | | | | | | | | | | | | | | |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the<br>conditions of<br>study the<br>device<br>extracts do<br>not pose a<br>systemic<br>toxicity<br>concern | --- | Under the conditions<br>of study the device<br>extracts did not reveal<br>any systemic toxicity | Similar | | | | | | | | | | | | | | | | | | |

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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | | Comparison |
|-----------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | | PREDICATE | REFERENCE | SUBJECT | |
| 510(k) Number | | K202377 | K192329 | K213073 | |
| Water Tight (1000 ml) | ASTM D5151-19<br>AQL-2.5 | Passes | Passes | Passes | Similar |
| Indication for Use | --- | Latex<br>Examination<br>Powder Free<br>Gloves are<br>disposable<br>devices<br>intended for<br>medical<br>purpose that are<br>worn on the<br>examiner's<br>hand to prevent<br>contamination<br>between<br>patient and<br>examiner. | Blue Latex<br>Examination<br>Powder Free<br>Gloves are<br>disposable<br>devices intended<br>for medical<br>purpose that are<br>worn on the<br>examiner's hand<br>to prevent<br>contamination<br>between<br>patient and<br>examiner. | Latex Examination<br>Powder Free Gloves<br>are disposable devices<br>intended for medical<br>purpose that is worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. | Similar |
| Material | --- | Natural Latex | Natural Latex | Natural Latex | Identical |
| Color | --- | Natural (No<br>color is<br>added) | Blue | Natural color (No<br>color is added) | Similar to<br>predicate<br>device |
| Size | ASTM D3578-19 | X Small,<br>Small,<br>Medium,<br>Large | Small, Medium,<br>Large, X<br>Large & XX<br>Large | X-Small, Small,<br>Medium, Large, X-<br>Large | Similar<br>(compared to<br>predicate and<br>reference<br>devices) |
| Single Use | Medical Glove<br>Guidance Manual-<br>Labeling | Single Use | Single Use | Single Use | Same |
| Sterile/nonsterile | --- | Nonsterile | Non sterile | Nonsterile | Similar |
| Powder/Powder free | --- | Powder free | Powder free | Powder free | Same |
| Label and Labeling | FDA Label<br>requirements | Meets FDA's<br>label and<br>labeling<br>requirements | Meets FDA's<br>label and<br>labeling<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Same |
| Manufacturer(s) | --- | Hi-Care Thai<br>Gloves Co.<br>Ltd. | JR Engineering<br>& Medical<br>Technologies<br>(M)<br>SDN BHD | THAI RUBBER<br>GLOVES CO., LTD. | --- |

There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. Devices meet the ASTM standard D3578-19.

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

### BENCH TEST DATA

| TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT |
|--------------------------------------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| ASTM D3578-19<br>Standard Specification for Rubber<br>Examination Gloves | To determine the<br>length of the gloves | Min 230 mm for all sizes | X-Small : 245 mm<br>Small : 244 mm<br>Medium : 247 mm<br>Large : 240 mm<br>X-Large : 247 mm |
| ASTM D3578-19<br>Standard Specification for Rubber<br>Examination Gloves | To determine the<br>width of the gloves | X-Small : 70+/-10 mm<br>Small : 80+/-10 mm<br>Medium : 95+/-10 mm<br>Large : 111+/-10 mm<br>X Large : 120+/-10 mm | X-Small : 77 mm<br>Small : 80 mm<br>Medium : 92 mm<br>Large : 101 mm<br>X-Large : 110 mm |

| TEST<br>METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT | | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|--------------|
| | | | | | |
| ASTM D3578-19<br>Standard<br>Specification for<br>Rubber<br>Examination Gloves | To determine the<br>thickness of the<br>gloves | Palm<br>0.08 mm min<br>for all sizes<br>Finger<br>0.08 mm min<br>for all sizes | Size | Palm | Finger |
| | | | X-Small | 0.115 mm | 0.125 mm |
| | | | Small | 0.115 mm | 0.128 mm |
| | | | Medium | 0.115 mm | 0.132 mm |
| | | | Large | 0.121 mm | 0.135 mm |
| | | | X Large | 0.109 mm | 0.122 mm |
| ASTM D3578-19<br>Standard<br>Specification for<br>Rubber<br>Examination Gloves | To determine the<br>physical properties-<br>Tensile strength | Before Ageing<br>Tensile Strength<br>18MPa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14MPa Min for all<br>sizes | Size | Before ageing | After ageing |
| | | | X-Small | 26.2 MPa | 24.1 MPa |
| | | | Small | 25.0 MPa | 24.1 MPa |
| | | | Medium | 24.0 MPa | 23.4 MPa |
| | | | Large | 22.6 MPa | 24.3 MPa |
| | | | X Large | 24.2 MPa | 22.5 MPa |
| ASTM D3578-19<br>Standard<br>Specification for<br>Rubber<br>Examination Gloves | To determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate<br>Elongation 650%<br>Min for all sizes<br>After Ageing<br>Ultimate<br>Elongation 500%<br>Min for all sizes | Size | Before ageing | After ageing |
| | | | X-Small | 830% | 800% |
| | | | Small | 790% | 760% |
| | | | Medium | 810% | 830% |
| | | | Large | 800% | 810% |
| | | | X Large | 800% | 780% |

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| TEST METHOD | PURPOSE | ACCEPTANCE<br>CRITERIA | RESULT |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151-19 Standard<br>Test Method for Detection<br>of Holes in Medical Gloves | To determine the holes<br>in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06<br>(Reapproved 2017) Standard<br>Test Method for Residual<br>Powder on Medical Gloves | To determine the<br>residual powder in the<br>gloves | $\leq$ 2 mg/glove | X-Small : 0.60 mg/glove<br>Small : 0.80 mg/glove<br>Medium : 1.46 mg/glove<br>Large : 0.62 mg/glove X-<br>Large : 1.13 mg/glove |
| ASTM D5712-15<br>(Reapproved 2020) Standard<br>Test Method for Analysis of<br>Aqueous Extractable Protein<br>in Latex, Natural Rubber, and<br>Elastomeric Products Using<br>the Modified Lowry Method | To determine the<br>extractable protein in<br>the gloves. | 200 $\mu$ g/ dm² Max | Medium : 191.9 $\mu$ g/ dm² |

### 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<br>item, for skin irritation<br>test in New Zealand<br>White rabbits. | Under the condition<br>of study, not an<br>irritant | Under the condition of<br>study, not an irritant |
| 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<br>item, for the skin<br>sensitization in Guinea<br>pigs by maximization<br>test. | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions of<br>the study, not a<br>sensitizer |
| ISO10993-5:2009(E)<br>Biological Evaluation of<br>Medical Devices - Part 5,<br>Tests for In Vitro<br>Cytotoxicity. | To evaluate the test<br>item, for its ability to<br>induce cytotoxicity<br>using L-929 mouse<br>fibroblast cells by<br>Elution Method. | Under the conditions<br>of the study, non-<br>cytotoxic | Under the conditions of<br>the study the device is<br>"cytotoxic" |
| ISO 10993-11:2017(E)<br>Biological Evaluation of<br>Medical Devices - Part 11,<br>Tests for Systemic Toxicity. | To evaluate the test<br>item, for acute systemic<br>toxicity in Swiss Albino<br>Mice. | Under the conditions<br>of study, the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Under the conditions<br>of study, the device<br>extracts did not reveal<br>any systemic toxicity |

{10}------------------------------------------------

The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).

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

ASTM D3578-19 Standard Specification for Rubber Examination Gloves

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

ASTM D5712-15 (Reapproved 2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method

ISO 10993-10:2010 (E) 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 conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(K) submission, Latex Examination Powder Free Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device K202377.