Goody Gloves, Wincare, TBG Gloves

K213075 · Thai Rubber Gloves Co., Ltd. · LZA · Jan 20, 2022 · General Hospital

Device Facts

• Record ID: K213075
• Device Name: Goody Gloves, Wincare, TBG Gloves
• Applicant: Thai Rubber Gloves Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Jan 20, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Blue Nitrile Examination Gloves Powder Free 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 nitrile (NBR) examination gloves; worn by healthcare examiners to provide barrier protection against cross-contamination between patient and examiner. Device is single-use; available in sizes X-Small through X-Large. Performance characteristics verified against ASTM D6319-19 standards for dimensions, tensile strength, and elongation. Biocompatibility confirmed via ISO 10993 testing series. No clinical data required.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including physical property testing (ASTM D6319-19), water-tightness (ASTM D5151-19), residual powder testing (ASTM D6124-06), and biocompatibility testing (ISO 10993-5, 10, and 11).

Technological Characteristics

Material: 100% Nitrile (NBR). Form factor: Ambidextrous, powder-free, blue, non-sterile. Standards: ASTM D6319-19 (physical properties/dimensions), ASTM D5151-19 (water-tightness), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. No specific patient population or contraindications described.

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 Powder free (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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 20, 2022

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

Re: K213075

Trade/Device Name: 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: December 20, 2021 Received: December 20, 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,

For 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 Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K213075

Device Name Blue Nitrile Examination Gloves Powder Free

### Indications for Use (Describe)

Blue Nitrile Examination Gloves Powder Free 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) | <span style="font-size: 20px;">☐</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☑</span> |

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## 510(K) SUMMARY K213075

### AS REQUIRED BY: 21CFR§807.92(C)

### A. APPLICANT INFORMATION

| 510(K) Owner's Name | THAI RUBBER GLOVES CO., LTD. |
|---------------------|----------------------------------------------------------------------|
| Address | 680 MOO 2 BANBUENG – KLAENG RD.,<br>NONGYAI CHONBURI 20190 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 | 13 September 2021 |

### B. DEVICE IDENTIFICATION

| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|-----------------------------------|---------------------------------------------|
| Product proprietary or trade name | Goody Gloves / Wincare / TBG Gloves |
| Common or usual name | Blue Nitrile Examination Gloves Powder Free |
| 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:

Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.

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

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

Blue Nitrile Examination Gloves Powder Free 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 | SUBJECT | |
| 510(K) Number | --- | K202384 | K213075 | |
| Name of device | --- | Palm Care Blue Nitrile<br>Examination Gloves<br>Powder free | Blue Nitrile<br>Examination Gloves<br>Powder free | --- |
| Dimensions - Length | ASTM D6319-19 | Length Min 230 mm | Length > 230 mm | Similar |
| | | | Size<br>Average | |
| | | | X-Small<br>250 | |
| | | | Small<br>241 | |
| | | | Medium<br>240 | |
| | | | Large<br>243 | |
| | | | X-Large<br>240 | |
| Dimensions - Width | ASTM D6319-19 | Width Min 95+/-10mm<br>(for medium size) | Width 95+/-10mm<br>(for medium size) | Similar |
| | | | Size<br>Average | |
| | | | X-Small<br>80 | |
| | | | Small<br>82 | |
| | | | Medium<br>93 | |
| | | | Large<br>103 | |
| | | | X-Large<br>110 | |
| Physical Properties-<br>Tensile Strength | ASTM D6319-19 | Before Ageing<br>Tensile Strength<br>min 14 MPa | Before Ageing<br>Tensile Strength > 14 MPa | Similar |
| | | | Size<br>Actual<br>value | |
| | | | X-Small<br>24.5 | |
| | | | Small<br>22.7 | |
| | | | Medium<br>25.3 | |
| | | | Large<br>26.4 | |
| | | | X-Large<br>25.5 | |
| | | After Ageing<br>Tensile Strength<br>min 14 MPa | After Ageing<br>Tensile Strength > 14 MPa | Similar |
| | | | Size<br>Actual<br>value | |
| | | | X-Small<br>23.8 | |
| | | | Small<br>24.3 | |
| | | | Medium<br>31.9 | |
| | | | Large<br>30.3 | |
| | | | X-Large<br>27.4 | |

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#

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | | | | | | | | | | | | | | | | | |
|---------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|---------|--|--|--|--|--|---------|
| | | PREDICATE | SUBJECT | | | | | | | | | | | | | | | | | | | |
| 510(K) Number | | K202384 | K213075 | | | | | | | | | | | | | | | | | | | |
| Physical Properties-<br>Ultimate Elongation | ASTM D6319-19 | Before Ageing<br>Ultimate Elongation<br>> 500% | Before Ageing<br>Ultimate Elongation > 500%<br>Size Actual value X-Small 620 Small 580 Medium 530 Large 540 X-Large 540 | | | | | | | | | | | | | Similar | | | | | | |
| | | After Ageing<br>Ultimate Elongation<br>> 400% | After Ageing<br>Ultimate Elongation > 400%<br>Size Actual value X-Small 590 Small 560 Medium 530 Large 540 X-Large 530 | | | | | | | | | | | | | Similar | | | | | | |
| Thickness | ASTM D6319-19 | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm > 0.05 mm Finger > 0.05 mm<br>Size Palm<br>(Actual<br>value) Finger<br>(Actual<br>value) X-Small 0.101 0.121 Small 0.089 0.103 Medium 0.100 0.116 Large 0.098 0.121 X-Large 0.094 0.114 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Residue | ASTM D6319-19 | <2 mg/glove | <2 mg/glove<br>Size Actual value X-Small 1.07 Small 1.49 Medium 0.62 Large 0.56 X-Large 1.60 | | | | | | | | | | | | | Similar | | | | | | |
| Biocompatibility | Primary Skin<br>Irritation- ISO 10993-<br>10:2010(E) | Under the condition<br>of study not an<br>irritant | Under the condition of study not<br>an irritant | Same | | | | | | | | | | | | | | | | | | |
| | Dermal Sensitization-<br>ISO 10993-10:2010(E) | Under the<br>conditions of the<br>study not a<br>sensitizer | Under the conditions of the study<br>not a sensitizer | Same | | | | | | | | | | | | | | | | | | |
| | In vitro cytotoxicity-<br>ISO 10993-5:2009(E) | Under the<br>conditions of the<br>study, noncytotoxic | Under the conditions of the study,<br>"non-cytotoxic" at 50%, 25%,<br>12.5% and 6.25% extracts | 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 | Under the conditions of study, the<br>device extracts did not reveal any<br>systemic toxicity | Same | | | | | | | | | | | | | | | | | | |

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| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|--------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | PREDICATE<br>K202384 | SUBJECT<br>K213075 | |
| 510(K) Number | --- | | | Similar |
| Water Tight<br>(1000 ml) | ASTM D5151-19<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 worn<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. | Blue Nitrile Examination<br>Gloves Powder Free are<br>disposable devices intended<br>for medical purpose that is<br>worn on the examiner's hand<br>to prevent contamination<br>between patient and examiner. | Similar |
| Material | ASTM D6319-19 | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | --- | Blue | Blue | Same |
| Size | ASTM D6319-19 | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Extra Small, Small, Medium,<br>Large, Extra Large | Same |
| Single Use | Medical Glove<br>Guidance<br>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<br>label and<br>labeling<br>requirements | Meets FDA's label and<br>labeling requirements | Meets FDA's label and labeling<br>requirements | Same |
| Manufacturer(s) | --- | Hi-Care Thai Gloves Co.<br>Ltd. | THAI RUBBER GLOVES CO.,<br>LTD.. | --- |

There are no significant differences between the two products and are identical in terms of intended use, materials, design and manufacturing methods. Both devices meet the ASTM standard D6319-19.

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# 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 : 250 mm<br>Small : 241 mm<br>Medium : 240 mm<br>Large : 243 mm<br>X-Large : 240 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+/-10 mm<br>Medium : 95+/-10 mm<br>Large : 110+/-10 mm<br>X-Large : 120+/-10 mm | X-Small : 80 mm<br>Small : 82 mm<br>Medium : 93 mm<br>Large : 103 mm<br>X-Large : 110 mm |

| 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>for all sizes<br>Finger<br>0.05 mm min<br>for all sizes | Size | Palm | Finger |
| | | | X-Small | 0.101 mm | 0.121 mm |
| | | | Small | 0.089 mm | 0.103 mm |
| | | | Medium | 0.100 mm | 0.116 mm |
| | | | Large | 0.098 mm | 0.121 mm |
| | | | X-Large | 0.094 mm | 0.114 mm |
| 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 | Before Ageing<br>Tensile Strength<br>14MPa 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 | 24.5 MPa | 23.8 MPa |
| | | | Small | 22.7 MPa | 24.3 MPa |
| | | | Medium | 25.3 MPa | 31.9 MPa |
| | | | Large | 26.4 MPa | 30.3 MPa |
| | | | X-Large | 25.5 MPa | 27.4 MPa |
| | To determine the<br>physical properties-<br>Ultimate Elongation | Before Ageing<br>Ultimate<br>Elongation<br>500% Min for all<br>sizes<br>After Ageing<br>Ultimate<br>Elongation 400%<br>Min for all sizes | Size | Before ageing | After ageing |
| | | | X-Small | 620% | 590% |
| | | | Small | 580% | 560% |
| | | | Medium | 530% | 530% |
| | | | Large | 540% | 540% |
| | | | X-Large | 540% | 530% |

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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 | ≤ 2 mg/glove | X-Small : 1.07 mg/glove<br>Small : 1.49 mg/glove<br>Medium : 0.62 mg/glove<br>Large : 0.56 mg/glove<br>X-Large : 1.60 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<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<br>of the study, the device<br>is 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 of<br>study, the device<br>extracts did not reveal<br>any systemic toxicity |

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 D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.

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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(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 conclusions drawn from the non-clinical test demonstrate that the subject devices in 510(K) submission, Goody Gloves / Wincare / TBG Gloves (Blue Nitrile Examination Gloves Powder Free) are as safe, as effective, and performs as well as or better than the legally marketed predicate device K202384.