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 Description

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.

AI/ML Overview

The document provided focuses on the substantial equivalence determination for PP CARE Nitrile Examination Gloves (K212629) based on non-clinical testing. It does not describe a clinical study or AI/algorithm performance. Therefore, many of the requested points are not applicable.

Here's the information that can be extracted from the provided text regarding the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance (PP CARE Nitrile Examination Gloves)	Standard / Test Method
Dimensions			ASTM D 6319-19
Length (Size L)	Min 230 mm	240 mm	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Width (Size L)	110 +/- 10 mm	105 mm	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Thickness	Palm: 0.05 mm min; Finger: 0.05 mm min	Palm: 0.10 mm; Finger: 0.15 mm	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Physical Properties			ASTM D 6319-19
Tensile Strength - Before Aging (Size L)	14 MPa Minimal	17 MPa	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Tensile Strength - After Aging (Size L)	14 MPa Minimal	20 MPa	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Ultimate Elongation - Before Aging (Size L)	500% Min	520%	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Ultimate Elongation - After Aging (Size L)	400% Min	512%	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Powder Residue	2 mg/glove Max	0.35 mg/glove	ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
Water Tightness	Number of samples tested: 200; Number of Leaks allowed: 7 (Implies AQL 1.5 pass rate)	Passed (AQL 1.5)	The Testing of unreferenced nitrile gloves in accordance with EN 455-1:2000
Biocompatibility	Under the condition of study not an irritant/sensitizer/non-cytotoxic (for predicate)
Skin Irritation	Not an irritant	Under the condition of study not an irritant	[As per ISO 10993-10:2010(E)] - SKIN IRRITATION TEST OF NITRILE EXAMINATION GLOVE, NON STERILE IN NEW ZEALAND WHITE RABBITS
Skin Sensitization	Not a sensitizer	Under the conditions of the study, not a sensitizer	[As per ISO 10993-10:2010(e)] - SKIN SENSITIZATION STUDY OF NITRILE EXAMINATION GLOVE, NON STERILE IN GUINEA PIGS BY MAXIMIZATION TEST
In Vitro Cytotoxicity	Non-cytotoxic	The sample was 100% cytotoxic (but acceptable due to systemic test)	[As per ISO 10993-5:2009(E)] - IN VITRO CYTOTOXICITY STUDY OF NITRILE EXAMINATION GLOVE, NON STERILE BY ELUTION METHOD
Acute Systemic Toxicity	N/A (Predicate did not perform this test)	Under the conditions of the study, the device was non-toxic	[As per ISO 10993-11:2017] - ACUTE SYSTEMIC TOXICITY STUDY OF NITRILE EXAMINATION GLOVE, NON STERILE IN SWISS ALBINO MICE

2. Sample size used for the test set and the data provenance:

Water Tightness Test: 200 samples were tested.
Data Provenance: The tests described are non-clinical (laboratory/materials testing) and were performed by EG Group Product and Service Co., Ltd. in Thailand. The data is thus prospective for the purpose of this submission and originates from Thailand.
For other tests like Dimensions, Physical Properties, Powder Residue, the sample sizes are not explicitly stated but are implied to be sufficient for demonstrating compliance with the respective ASTM standards.
For biocompatibility tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity), specific animal models are mentioned (New Zealand White Rabbits, Guinea Pigs, Swiss Albino Mice), indicating laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This document describes non-clinical performance and biocompatibility testing of medical gloves, not a study requiring expert clinical judgment for ground truth. The "ground truth" here is compliance with established international standards (ASTM, ISO, EN).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not a study involving human readers or AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This document is about medical gloves, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's performance against its acceptance criteria is defined by compliance with established international standards (ASTM D6319-19, EN 455-1:2000) and ISO 10993 series for biocompatibility. These standards set the benchmarks for physical properties, barrier integrity, and biological safety.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning study.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/machine learning study.

Summary of the Study that Proves Device Meets Acceptance Criteria:

The device's compliance with acceptance criteria is demonstrated through a series of non-clinical tests performed in accordance with recognized international standards. These tests assessed:

Dimensional properties: Length, width, and thickness as per ASTM D6319-19.
Physical properties: Tensile strength and ultimate elongation (before and after aging) as per ASTM D6319-19.
Powder Residue: Measurement of powder content as per ASTM D6319-19.
Water Tightness: To detect holes, conducted in accordance with EN 455-1:2000.
Biocompatibility:
- Skin Irritation (ISO 10993-10:2010(E) using New Zealand White Rabbits)
- Skin Sensitization (ISO 10993-10:2010(e) using Guinea Pigs)
- In Vitro Cytotoxicity (ISO 10993-5:2009(E) by elution method)
- Acute Systemic Toxicity (ISO 10993-11:2017 using Swiss Albino Mice)

The results show that the PP CARE Nitrile Examination Gloves meet or exceed all specified acceptance criteria derived from these standards for physical and barrier properties, and demonstrate acceptable biocompatibility (despite an "100% cytotoxic" in vitro result, which was mitigated by a successful acute systemic toxicity test, deeming the device non-toxic under study conditions). These non-clinical tests collectively provide the evidence that the device meets its performance requirements and is substantially equivalent to the predicate device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: info@eggroup.co.th Tel. 099-2932398 Line: @eggroup TEL: 02- 077-9550

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 +6638-320-999 +6638-320-999 ceo.info@egroup.co.th Ms.Pakkaporn Phattanaliampaiboon President +6638-320-999 ceo.info@egroup.co.th 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:

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: info@eggroup.co.th Tel. 099-2932398 Line: @eggroup TEL: 02- 077-9550

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 NitrileExaminationGloves PowderFree	PP CARE NitrileExamination Gloves	----
Dimensions	ASTM D 6319-19	Length Min 230 mm Width Min110+10/mm (For Large size)	Length Min 240 mmWidth Min 105 mm(For Large size)	Passed
PhysicalProperties	ASTM D 6319-19	Before AgingTensile Strengthmin 14 MpaUltimateElongationMin 500%After AgingTensile Strengthmin 14 MpaUltimateElongation Min400%	Before AgingTensile Strengthmin 17 MpaUltimate ElongationMin 520%After AgingTensile Strengthmin 20 MpaUltimate ElongationMin 512%	Passed
Thickness	ASTM D 6319-19	Palm min 0.05 mmFinger min 0.05mm	Palm min 0.10 mmFinger min 0.15 mm	Passed
Powder Residue	ASTM D 6319-19	<2mg/glove	0.35 mg/glove	Passed
Biocompatibility	SKIN IRRITATIONTEST OF NITRILEEXAMINATIONGLOVE, NONSTERILE IN NEWZEALAND WHITERABBITS[As per ISO 10993-10:2010(E)]	Under thecondition of studynot an irritant	Under the conditionof study not anirritant	Same
	SKIN SENSITIZATIONSTUDY OF NITRILEEXAMINATIONGLOVE, NONSTERILE IN GUINEAPIGS BYMAXIMIZATIONTEST[As per ISO 10993-10:2010(e)]	Under thecondition of studynot a sensitizer	Under the conditionsof the study, not asensitizer	Same
	IN VITROCYTOTOXICITYSTUDY OF NITRILEEXAMINATIONGLOVE, NONSTERILE BY ELUTIONMETHOD[As per ISO 10993-5:2009(E)]	Under theconditionsof the study, non-cytotoxic	Under the conditionsof the study, thesample was 100%cytotoxic	Different
	ACUTE SYSTEMICTOXICITY STUDY OFNITRILEEXAMINATIONGLOVE, NONSTERILE IN SWISSALBINO MICE[As per ISO 10993-11:2017]	Predicate devicedid not performthis test	Under the conditionsof the study, thedevice was non-toxic	Different
Water Tight(2000)	The Testing ofunreferenced nitrilegloves in accordancewith EN 455-1:2000	Passes AQL-1.5	Passes AQL-1.5	Passed
Intended use		Blue NitrileExaminationGloves PowderFree is disposabledevices intendedfor medicalpurpose that areworn on theexaminer's hand topreventcontaminationbetween patientand examiner.	The PP Care NitrileExamination Glovesis a disposabledevices intended formedical purposesthat are worn on theexaminer's hands topreventcontaminationbetween patient andexaminer.	Same
Material	Meet therequirements ofEN455-1:2000,EN455-2:2015, ISO21171:2016,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 ThaiGloves Co., Ltd.Thailand	EG Group Productand Service Co., Ltd.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: info@eggroup.co.th Tel. 099-2932398 Line: @eggroup TEL: 02- 077-9550

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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: info@eggroup.co.th Tel. 099-2932398 Line: @eggroup TEL: 02- 077-9550

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 StandardSpecification for NitrileExamination Gloves forMedical Application	To determine thelength of thegloves	Min 230 mm for size L	Large : 240 mm
ASTM D6319-19 StandardSpecification for NitrileExamination Gloves forMedical Application	To determine thewidth of thegloves	Large : 110 +/-10 mm	Large : 105 mm
ASTM D6319-19 StandardSpecification for NitrileExamination Gloves forMedical Application	To determine thethickness of thegloves	Palm 0.05 mm minFinger 0.05 mm minFor all sizes	Size Palm Finger Large 0.10 mm 0.15 mm
The Testing of unreferencednitrile gloves in accordance	To determine theholes in the gloves	Number of samplestested : 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: info@eggroup.co.th Tel. 099-2932398 Line: @eggroup TEL: 02- 077-9550

with EN 455-1 : 2000		Number of Leaksallowed : 7
ASTM D6319-19 StandardSpecification for NitrileExamination Gloves forMedical Application	To determine theresidual powder inthe gloves	2 Mg/Glove Max	SizeLarge	Residual PowderContent0.35 mg/glove
ASTM D6319-19 StandardSpecification for NitrileExamination Gloves forMedical Application	To Determine thephysicalproperties-Tensilestrength	Before AgingTensile Strength14 MPa Minimal forLarge sizeAfter AgingTensile Strength 14MPa for Large size	SizeLarge	Beforeageing17MPa	Afterageing20MPa
	To Determine thephysicalproperties-UltimateElongation	Before AgingUltimate Elongation500% Min for LargesizeAfter AgingUltimate Elongation400% Min for Largesize	SizeLarge	Beforeageing520%	Afterageing512%

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.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.