PP Care Nitrile Examination Gloves

K212629 · Eg Group Product and Services Co., Ltd. · LZA · May 26, 2022 · General Hospital

Device Facts

• Record ID: K212629
• Device Name: PP Care Nitrile Examination Gloves
• Applicant: Eg Group Product and Services Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: May 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn by healthcare examiners; prevents cross-contamination between patient and examiner. Manufactured from acrylonitrile butadiene rubber; blue color; powder-free; finger-textured. Device provides physical barrier protection. Used in clinical settings. Benefits patient and clinician by reducing risk of infection transmission during examinations.

Clinical Evidence

No clinical data. Bench testing only, including ASTM D6319-19 physical property testing (tensile strength, elongation, dimensions), thickness, powder residue, water-tightness (EN 455-1), and ISO 10993 biocompatibility testing (irritation, sensitization, cytotoxicity, acute systemic toxicity).

Technological Characteristics

Material: Acrylonitrile butadiene rubber (Nitrile). Form factor: Disposable, powder-free, blue, finger-textured. Standards: ASTM D6319-19, EN 455-1:2000, ISO 10993-5, 10, 11. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands 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

• 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 26, 2022

EG Group Product and Services CO., Ltd % Tim Kania Official Correspondent MDI Consultants Inc. 55 Northen Blvd. Suite 200 Great Neck, New York 11021

Re: K212629

Trade/Device Name: PP Care Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 25, 2022 Received: April 26, 2022

Dear Tim Kania:

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.

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)

K212629

Device Name PP CARE Nitrile Examination Gloves

#### Indications for Use (Describe)

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

Type 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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Image /page/3/Picture/0 description: The image shows a logo with the letters 'EG' in a stylized font. The 'E' is colored in orange, while the 'G' is in green. The letters are surrounded by a circular design, with the top half of the circle in green and the bottom half in orange. There are two orange dots on either side of the circle, connecting the top and bottom halves.

office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand

e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

510(K) SUMMARY K212629

### A. APPLICANT INFORMATION

510(K) Owner's Name Address

- Phone Fax E-mail Contact Person Title Contact Number Contact Email Date 510(K) summary prepared
EG GROUP PRODUCT AND SERVICE CO., LTD 27/58 MOO 8, Tumbon Buen, Sriracha District Sriracha, Chonburu , Thailand 20230 [phone] [phone] [e-mail] Ms.Pakkaporn Phattanaliampaiboon President [phone] [e-mail] February 8th ,2021

#### DEVICE IDENTIFICATION B.

Name of the device Product proprietary or trade name

Common or usual name Classification name Device Classification Product Code Regulation Number Review Panel

PP CARE Nitrile Examination Gloves PP CARE Nitrile Examination Gloves

Nitrile Examination Gloves POLYMER PATIENT EXAMINATION GLOVE Class-l LZA 21 CFR 880.6250 General Hospital

## C. PREDICATE DEVICE

Predicate Device 510(k) Number Regulatory Class l LZA Product code

Hi-Care Thai Gloves Co., Ltd K202384

## D. DESCRIPTION OF THE DEVICE:

PP CARE Nitrile Examination Gloves are Class I patient examination gloves bearing the product code LZA (21CFR880.6250). The gloves are made from acrylonitrile butadiene rubber. These gloves are blue in color and are powder free.

## E. INTENDED USE OF THE DEVICE:

The PP CARE Nitrile Examination Gloves is a disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

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Image /page/4/Picture/0 description: The image is a logo with the letters 'EG' in a stylized font. The 'E' is orange with a gold outline, and the 'G' is green. The letters are surrounded by a circular design, with the top half being green and the bottom half being orange. There are two small circles on either side of the circular design, one on the top left and one on the bottom right.

EG GROUP PRODUCT AND SERVICE CO., LTD office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand.

e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

## F. Summary of The Technological Characteristics of the device compared to the predicate Device

| CHARACTERISTIC | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | PREDICATE | SUBJECT | |
| 510(K) Number | | K202384 | K212629 | |
| Name of Device | | Blue Nitrile<br>Examination<br>Gloves Powder<br>Free | PP CARE Nitrile<br>Examination Gloves | ---- |
| Dimensions | ASTM D 6319-19 | Length Min 230 mm Width Min<br>110+10/mm (For Large size) | Length Min 240 mm<br>Width Min 105 mm<br>(For Large size) | Passed |
| Physical<br>Properties | ASTM D 6319-19 | Before Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate<br>Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate<br>Elongation Min<br>400% | Before Aging<br>Tensile Strength<br>min 17 Mpa<br>Ultimate Elongation<br>Min 520%<br>After Aging<br>Tensile Strength<br>min 20 Mpa<br>Ultimate Elongation<br>Min 512% | Passed |
| Thickness | ASTM D 6319-19 | Palm min 0.05 mm<br>Finger min 0.05<br>mm | Palm min 0.10 mm<br>Finger min 0.15 mm | Passed |
| Powder Residue | ASTM D 6319-19 | <2mg/glove | 0.35 mg/glove | Passed |
| Biocompatibility | SKIN IRRITATION<br>TEST OF NITRILE<br>EXAMINATION<br>GLOVE, NON<br>STERILE IN NEW<br>ZEALAND WHITE<br>RABBITS<br>[As per ISO 10993-<br>10:2010(E)] | Under the<br>condition of study<br>not an irritant | Under the condition<br>of study not an<br>irritant | Same |
| | SKIN SENSITIZATION<br>STUDY OF NITRILE<br>EXAMINATION<br>GLOVE, NON<br>STERILE IN GUINEA<br>PIGS BY<br>MAXIMIZATION<br>TEST<br>[As per ISO 10993-<br>10:2010(e)] | Under the<br>condition of study<br>not a sensitizer | Under the conditions<br>of the study, not a<br>sensitizer | Same |
| | IN VITRO<br>CYTOTOXICITY<br>STUDY OF NITRILE<br>EXAMINATION<br>GLOVE, NON<br>STERILE BY ELUTION<br>METHOD<br>[As per ISO 10993-<br>5:2009(E)] | Under the<br>conditions<br>of the study, non-<br>cytotoxic | Under the conditions<br>of the study, the<br>sample was 100%<br>cytotoxic | Different |
| | ACUTE SYSTEMIC<br>TOXICITY STUDY OF<br>NITRILE<br>EXAMINATION<br>GLOVE, NON<br>STERILE IN SWISS<br>ALBINO MICE<br>[As per ISO 10993-<br>11:2017] | Predicate device<br>did not perform<br>this test | Under the conditions<br>of the study, the<br>device was non-toxic | Different |
| Water Tight<br>(2000) | The Testing of<br>unreferenced nitrile<br>gloves in accordance<br>with EN 455-1:2000 | Passes AQL-1.5 | Passes AQL-1.5 | Passed |
| Intended use | | Blue Nitrile<br>Examination<br>Gloves Powder<br>Free is disposable<br>devices intended<br>for medical<br>purpose that are<br>worn on the<br>examiner's hand to<br>prevent<br>contamination<br>between patient<br>and examiner. | The PP Care Nitrile<br>Examination Gloves<br>is a disposable<br>devices intended for<br>medical purposes<br>that are worn on the<br>examiner's hands to<br>prevent<br>contamination<br>between patient and<br>examiner. | Same |
| Material | Meet the<br>requirements of<br>EN455-1:2000,<br>EN455-2:2015, ISO<br>21171:2016,<br>EN1186-1,2,3:2002 | Nitrile (NBR) | Nitrile (NBR) | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger Texture | Same |
| Size | | Large | Large | Same |
| Single use | | Single use | Single use | Same |
| Manufacturer(s) | | Hi-Care Thai<br>Gloves Co., Ltd.<br>Thailand | EG Group Product<br>and Service Co., Ltd.<br>Thailand | Same |

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Image /page/5/Picture/0 description: The image is a logo with the letters "EG" in a stylized font. The "E" is orange with a white outline, and the "G" is green. A green arc with a green circle at the end curves over the top of the letters, and an orange arc with an orange circle at the end curves under the letters. The arcs appear to be orbiting the letters.

office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand.

e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

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Image /page/6/Picture/0 description: The image is a logo with the letters "EG" in a stylized font. The "E" is orange with a white outline, and the "G" is green with a white outline. The letters are surrounded by a circular design, with the top half of the circle being green and the bottom half being orange. There are two small circles, one at the top right and one at the bottom left, where the green and orange lines meet. The logo has a clean and modern look.

office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand.

e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

There are no significant differences between the two products and are identical in terms of intended use, materials, manufacturing methods. The subject device was cytotoxic under the study, these conditions are not similar to the intended use conditions and as such a systemic toxicity test was performed. The systemic toxicity test demonstrates that the subject device is not toxic under the study. Both devices meet the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

## G. Non-Clinical Testing Summary

| Test Method | Purpose | Acceptance Criteria | Result | | | | | | |
|------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------|------------------------------------------|--|--|--|--|--|--|
| ASTM D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>length of the<br>gloves | Min 230 mm for size L | Large : 240 mm | | | | | | |
| ASTM D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>width of the<br>gloves | Large : 110 +/-10 mm | Large : 105 mm | | | | | | |
| ASTM D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>thickness of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min<br>For all sizes | Size Palm Finger Large 0.10 mm 0.15 mm | | | | | | |
| The Testing of unreferenced<br>nitrile gloves in accordance | To determine the<br>holes in the gloves | Number of samples<br>tested : 200 | Passed | | | | | | |

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Image /page/7/Picture/0 description: The image shows a logo with the letters 'EG' in a stylized font. The 'E' is colored orange, while the 'G' is green. The letters are surrounded by a circular design, with the top half of the circle being green and the bottom half being orange. There are small circular dots at the ends of the orange portion of the circle.

office : 168/72 Nakniwat Road, Lat Phrao, Lat Phrao, Bangkok 10230 factory : 27/58 M8, Tambon Bueng, Si Racha, Chonburi 20230 Thailand.

#### e-mail: [e-mail] Tel. [phone] Line: @eggroup TEL: [phone]

| with EN 455-1 : 2000 | | Number of Leaks<br>allowed : 7 | | | |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------|----------------------------------------|
| ASTM D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>residual powder in<br>the gloves | 2 Mg/Glove Max | Size<br>Large | Residual Powder<br>Content<br>0.35 mg/glove | |
| ASTM D6319-19 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To Determine the<br>physical<br>properties-Tensile<br>strength | <b>Before Aging</b><br>Tensile Strength<br>14 MPa Minimal for<br>Large size<br><b>After Aging</b><br>Tensile Strength 14<br>MPa for Large size | Size<br>Large | <b>Before</b><br><b>ageing</b><br>17MPa | <b>After</b><br><b>ageing</b><br>20MPa |
| | To Determine the<br>physical<br>properties-<br>Ultimate<br>Elongation | <b>Before Aging</b><br>Ultimate Elongation<br>500% Min for Large<br>size<br><b>After Aging</b><br>Ultimate Elongation<br>400% Min for Large<br>size | Size<br>Large | <b>Before</b><br><b>ageing</b><br>520% | <b>After</b><br><b>ageing</b><br>512% |

## H. Clinical Testing Summary

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

#### l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, The PP Care Nitrile Examination Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device, Blue Nitrile Examination Gloves Powder Free cleared under K202384.