Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Device Description

The subject device in this 510(k) Notification is Stronghold Group Nitrile Examination Glove, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250. Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

The Stronghold Group Nitrile Examination Gloves, Powder Free, device performance was evaluated through non-clinical testing to demonstrate substantial equivalence to a legally marketed predicate device (K203191).

1. Acceptance Criteria and Reported Device Performance

The device performance was evaluated against the standards outlined in ASTM D6319-19 and ISO 10993 for various physical properties and biocompatibility. The table below summarizes the acceptance criteria and the reported results:

Test Method	Acceptance Criteria	Reported Device Performance	Result
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Width)	Width: 91 mm (Mean) (for medium size)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Length)	Length: 241 mm (Mean) (for medium size)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Thickness: Finger)	Thickness: Finger – 0.13 mm (Mean)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Thickness: Palm)	Thickness: Palm – 0.09 mm (Mean)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Tensile Strength Before Aging)	Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Ultimate Elongation Before Aging)	Before Acceleration Aging: Ultimate Elongation (%): 601 (Mean)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Tensile Strength After Aging)	After Acceleration Aging: Tensile Strength (MPa): 34 (Mean)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Ultimate Elongation After Aging)	After Acceleration Aging: Ultimate Elongation (%): 571 (Mean)	Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed")	Passed
ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves	AQL 2.5	Passed	Passed
ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves	≤ 2.0 mg/glove	0.12 mg/glove	Passed
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization (Irritation)	Under the condition of study not an irritant	Under the condition of study not an irritant	Passed
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization (Sensitization)	Under the conditions of the study not a sensitizer.	Under the conditions of the study not a sensitizer.	Passed
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Under the conditions of study non cytotoxic	Non-cytotoxic reactivity at 100%, 50%, 25%, 12.5% and 6.25% extract concentration. (This indicates it was non-cytotoxic across all tested concentrations, meeting or exceeding the "non-cytotoxic" acceptance criteria).	Passed
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity	Under the conditions of the study no systemic toxicity	Under the conditions of the study no systemic toxicity	Passed
ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for skin irritation	Under the conditions of the study, no skin irritation	Under the conditions of the study, no skin irritation	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each non-clinical test conducted for the Stronghold Group Nitrile Examination Gloves. However, tests were conducted according to established ASTM and ISO standards, which typically specify minimum sample sizes for valid results.

The data provenance is from non-clinical testing (laboratory-based testing) of the Stronghold Group Nitrile Examination Gloves. The country of origin for the data is not specified directly in the provided text, but the testing was for a device manufactured by Stronghold Group. The testing is prospective in the sense that it evaluates the performance of the manufactured device directly.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation involved non-clinical laboratory testing against established physical and chemical standards (ASTM, ISO), rather than a clinical study requiring expert interpretation of results or ground truth establishment by medical experts. The "ground truth" for these tests is defined by the objective measurement criteria of the standards themselves.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involved non-clinical laboratory testing with objective pass/fail criteria from recognized standards, not a process that would require expert adjudication.

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

This information is not applicable. The device is a "Nitrile Examination Glove, Powder Free" and does not involve AI or human reader interpretation. The testing focuses on the physical and biocompatibility properties of the glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable, as the device is a physical medical glove and does not involve any algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established standard specifications and methodologies from ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example, for dimensions, the ground truth is the specified range in ASTM D6319-19; for cytotoxicity, it's the qualitative assessment of "non-cytotoxic" based on ISO 10993-5.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical glove, and its performance evaluation did not involve machine learning models that require a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as above (no training set for a physical device).

Summary

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January 13, 2022

Stronghold Group LLC % Prithul Bom Mosr Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K213859

Trade/Device Name: Stronghold Group Nitrile Examination Glove, 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 8, 2021 Received: December 10, 2021

Dear Prithul Bom:

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 mediation-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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213859

Device Name

Stronghold Group Nitrile Examination Gloves, Powder Free

Indications for Use (Describe)

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

STRONGHOLD GROUP NITRILE EXAMINATION GLOVES, POWDER FREE

Preparation Date: July 22, 2021

1. SUBMITTER

Company Name: Stronghold Group Company Address: 3409-B Ainslie Street, Philadelphia, PA 19129 Contact Person: David Henderson Telephone Number: +1.215.350.8855 Email: Dave@strongholdcare.com

2. NAME OF THE DEVICE

Trade Name / Proprietary Name: Stronghold Group Nitrile Examination Gloves, Powder Free Device Name: Stronghold Group Nitrile Examination Gloves, Powder Free Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA

3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Predicate Device: K203191 Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital

4. DEVICE DESCRIPTION

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5. INTENDED USE OF THE DEVICE

6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES

	DEVICE PERFORMANCE
CHARACTERISTICS	PREDICATE	SUBJECT	Remarks
510(k) Number	K203191	TBD
Device Name	Nitrile ExaminationGloves, Powder Free	Nitrile ExaminationGloves, Powder Free	Same
Product Code	LZA	LZA	Same
Intended Use	LYDUS NitrileExamination Gloves,Powder Free is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand or fingers toprevent contaminationbetween patient andexaminer.	Stronghold Group NitrileExamination Gloves,Powder Free is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor fingers to preventcontamination betweenpatient and examiner.	Same
Materials of Use(ASTMD6910/D6910M-19)	Nitrile compound	Nitrile compound	Same
Color	Blue	Blue	Same
Texture	Finger Textured	Finger Textured	Same
Size(ASTM D6319-19)	Small, Medium,Large, Extra Large	Small, Medium, Large,Extra Large	Same
Sterilization	Non-sterile	Non-sterile	Same
Usage	Single usage	Single usage	Same
Dimensions(ASTM D6319-19)	Length Min. 230 minWidth Min 95+/-10mm (for medium size)	Length Min. 230 minWidth Min 95+/-10 mm(for medium size)	Same
Physical Properties(ASTM D6319-19)	Before AgingTensile StrengthMin 14 MpaUltimate ElongationMin 500%After AgingTensile StrengthMin 14 MpaUltimate Elongation	Before AgingTensile StrengthMin 14 MpaUltimate ElongationMin 500%After AgingTensile StrengthMin 14 MpaUltimate Elongation	Same
	Min 400%
Thickness(ASTM D6319-19)	Palm min 0.05 mmFinger min 0.05 mm	Palm min 0.05 mmFinger min 0.05 mm	Same
Powder Free(ASTM D6319-19)	≤2 mg/glove	≤2 mg/glove	Same
Freedom from Holes(Water Tight -1000 ml) -ASTM D6319-19 (CrossReference D5151)	Passed	Passed	Same
Biocompatibility -SKIN SENSITIZATION -ISO 10993-10: 2010(E)	Under the conditionsof study not anirritant	Under the conditions ofstudy not an irritant	Same
Biocompatibility -SKIN IRRITATION -ISO 10993-10: 2010(E)	Under the conditionsof the study not asensitizer	Under the conditions ofthe study not asensitizer	Same
Biocompatibility - INVITROCYTOTOXICITY - ISO10993-5: 2009(E)	Exhibit cytotoxicreactivity at 100%extract concentration(Grade 4 with neatextract).Non-cytotoxicreactivity at 50%,25%, 12.5% and6.25% extractconcentration.	Non-cytotoxic reactivityat all extractconcentrations.	Similar
Biocompatibility -ACUTE SYSTEMICTOXICITY - ISO10993-11: 2017(E)	No systemic toxicityunder theexperimentalconditions employed	No systemic toxicityunder the experimentalconditions employed	Same
Biocompatibility – SkinIrritation Test - ISO10993-23 : 2021(E)	N/A	Report results show asnon-irritant	Similar
Manufacturer(s)	Nathan Trading Co.,Ltd., Thailand	Stronghold Group

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

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8. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria	Result
ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication -PhysicalDimensions Test	To determinethe width,length, andthickness ofthe gloves	Width:91 mm(Mean)(formediumsize)Length:241 mm (Mean)(for mediumsize)Thickness: Finger –0.13 mm (Mean)Palm – 0.09 mm(Mean)	Passed
ASMT D6319-19StandardSpecification forNitrile ExaminationGloves for MedicalApplication -PhysicalRequirements Test	To determinethe tensilestrength andultimateelongationbefore andafteraccelerationaging	Before Acceleration Aging:TensileStrength (MPa): 34 (Mean)Ultimate Elongation (%): 601(Mean)After Acceleration Aging:Tensile Strength (MPa): 34 (Mean)Ultimate Elongation (%): 571(Mean)	Passed
ASTM D6319-19(ASTM D5151-11)Standard TestMethod forDetection of Holesin Medical Gloves	To determinethe holes inthe gloves	AQL 2.5	Passed
ASMT D6319-19(ASTM D6124-11)Standard TestMethod for ResidualPowder on MedicalGloves	To determinethe residualpowder in thegloves	$\leq$ 2.0 mg/glove	0.12mg/glove
Test Method	Purpose	AcceptanceCriteria	Result
ISO 10993-10 Biologicalevaluation of medicaldevices - Part 10: Testsfor skin irritation and skinsensitization	To determine the potential ofthe material under test toproduce skin irritation inrabbits	Under thecondition ofstudy not anirritant	Under thecondition ofstudy not anirritant
ISO 10993-10 Biologicalevaluation of medicaldevices - Part 10: Testsfor skin irritation and skinsensitization	To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inguinea pigs.	Under theconditions of thestudy not asensitizer.	Under theconditions of thestudy not asensitizer.
ISO 10993-5 Biologicalevaluation of medicaldevices - Part 5: Testsfor in vitro cytotoxicity	To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method	Under theconditions ofstudy noncytotoxic	Non-cytotoxicreactivity at100%, 50%,25%, 12.5% and6.25% extractconcentration.
ISO 10993-11:2017Biological evaluation ofmedical devices - Part11: Tests for acutesystemic toxicity	The test item was evaluatedfor acute systemic toxicity inAlbino Mice	Under theconditions of thestudy nosystemic toxicity	Under theconditions of thestudy nosystemictoxicity
ISO 10993-23 : 2021Biological evaluation ofmedical devices Part 23:Tests for skin irritation	The test item was evaluatedfor skin irritation using in vitroreconstructed humanepidermis model EpiDermSkin Irritation Test	Under theconditions of thestudy, no skinirritation	Under theconditions of thestudy, no skinirritation

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9. BIO-COMPATIBILITY DATA

10. CLINICAL TESTING SUMMARY

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

11. CONCLUSION

The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(k) submission, the Stronghold Group Nitrile Examination Gloves, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203191.

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.