K Number

Device Name

Stronghold Group Nitrile Examination Glove, Powder Free

Manufacturer

Stronghold Group LLC

Date Cleared

2022-01-13

(34 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K203191

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple examination glove and the summary contains no mention of AI or ML.

Therapeutic

No
The device is described as an examination glove intended to prevent contamination, which is a protective and diagnostic function rather than a therapeutic one.

Diagnostic

No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device is a physical glove made of nitrile, not software. The description explicitly states it is a disposable device worn on the hand or fingers and is made from a nitrile compound.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device 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." This describes a barrier device used externally.
Device Description: The description confirms it's a "patient examination glove made from nitrile compound."
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other substances to perform tests.

IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LZA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed as follows:

ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test: Determined the width, length, and thickness of the gloves. Result: Passed. Width: 91 mm (Mean) (for medium size), Length: 241 mm (Mean) (for medium size), Thickness: Finger – 0.13 mm (Mean), Palm – 0.09 mm (Mean).
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test: Determined the tensile strength and ultimate elongation before and after acceleration aging. Result: Passed. Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 601 (Mean). After Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 571 (Mean).
ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves: Determined the holes in the gloves. Result: Passed, AQL 2.5.
ASTM D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves: Determined the residual powder in the gloves. Result: 0.12 mg/glove (Acceptance Criteria: ≤ 2.0 mg/glove).
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization (skin irritation): Determined the potential of the material to produce skin irritation in rabbits. Result: Under the condition of study not an irritant.
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization (skin sensitization): Determined the skin sensitization potential of the material in guinea pigs. Result: Under the conditions of the study not a sensitizer.
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity: Evaluated the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells using elution method. Result: Non-cytotoxic reactivity at 100%, 50%, 25%, 12.5% and 6.25% extract concentration.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity: Evaluated for acute systemic toxicity in Albino Mice. Result: Under the conditions of the study no systemic toxicity.
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for skin irritation: Evaluated for skin irritation using in vitro reconstructed human epidermis model EpiDerm Skin Irritation Test. Result: Under the conditions of the study, no skin irritation.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K203191

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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.

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

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

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 Examination
Gloves, Powder Free	Nitrile Examination
Gloves, Powder Free	Same
Product Code	LZA	LZA	Same
Intended Use	LYDUS 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.	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.	Same
Materials of Use
(ASTM
D6910/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 min
Width Min 95+/-10
mm (for medium size)	Length Min. 230 min
Width Min 95+/-10 mm
(for medium size)	Same
Physical Properties
(ASTM D6319-19)	Before Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation
Min 500%
After Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation	Before Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation
Min 500%
After Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation	Same
	Min 400%
Thickness
(ASTM D6319-19)	Palm min 0.05 mm
Finger min 0.05 mm	Palm min 0.05 mm
Finger 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 (Cross
Reference D5151)	Passed	Passed	Same
Biocompatibility -
SKIN SENSITIZATION -
ISO 10993-10: 2010
(E)	Under the conditions
of study not an
irritant	Under the conditions of
study not an irritant	Same
Biocompatibility -
SKIN IRRITATION -
ISO 10993-10: 2010
(E)	Under the conditions
of the study not a
sensitizer	Under the conditions of
the study not a
sensitizer	Same
Biocompatibility - IN
VITRO
CYTOTOXICITY - ISO
10993-5: 2009(E)	Exhibit cytotoxic
reactivity at 100%
extract concentration
(Grade 4 with neat
extract).
Non-cytotoxic
reactivity at 50%,
25%, 12.5% and
6.25% extract
concentration.	Non-cytotoxic reactivity
at all extract
concentrations.	Similar
Biocompatibility -
ACUTE SYSTEMIC
TOXICITY - ISO
10993-11: 2017(E)	No systemic toxicity
under the
experimental
conditions employed	No systemic toxicity
under the experimental
conditions employed	Same
Biocompatibility – Skin
Irritation Test - ISO
10993-23 : 2021(E)	N/A	Report results show as
non-irritant	Similar
Manufacturer(s)	Nathan Trading Co.,
Ltd., Thailand	Stronghold Group

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.

8. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria
ASMT D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application -
Physical
Dimensions Test	To determine
the width,
length, and
thickness of
the gloves	Width:
91 mm
(Mean)
(for
medium
size)
Length:
241 mm (Mean)(for medium
size)
Thickness: Finger –
0.13 mm (Mean)
Palm – 0.09 mm
(Mean)	Passed
ASMT D6319-19
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application -
Physical
Requirements Test	To determine
the tensile
strength and
ultimate
elongation
before and
after
acceleration
aging	Before Acceleration Aging:
Tensile
Strength (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 Test
Method for
Detection of Holes
in Medical Gloves	To determine
the holes in
the gloves	AQL 2.5	Passed
ASMT D6319-19
(ASTM D6124-11)
Standard Test
Method for Residual
Powder on Medical
Gloves	To determine
the residual
powder in the
gloves	$\leq$ 2.0 mg/glove	0.12
mg/glove
Test Method	Purpose	Acceptance
Criteria	Result
ISO 10993-10 Biological
evaluation of medical
devices - Part 10: Tests
for skin irritation and skin
sensitization	To determine the potential of
the material under test to
produce skin irritation in
rabbits	Under the
condition of
study not an
irritant	Under the
condition of
study not an
irritant
ISO 10993-10 Biological
evaluation of medical
devices - Part 10: Tests
for skin irritation and skin
sensitization	To determine the skin
sensitization potential of the
material both in terms of
induction and elicitation in
guinea pigs.	Under the
conditions of the
study not a
sensitizer.	Under the
conditions of the
study not a
sensitizer.
ISO 10993-5 Biological
evaluation of medical
devices - Part 5: Tests
for in vitro cytotoxicity	To evaluate the in vitro
cytotoxic potential of the test
item (both inner and outer
surface) Extracts in L-929
mouse fibroblasts cells using
elution method	Under the
conditions of
study non
cytotoxic	Non-cytotoxic
reactivity at
100%, 50%,
25%, 12.5% and
6.25% extract
concentration.
ISO 10993-11:2017
Biological evaluation of
medical devices - Part
11: Tests for acute
systemic toxicity	The test item was evaluated
for acute systemic toxicity in
Albino Mice	Under the
conditions of the
study no
systemic toxicity	Under the
conditions of the
study no
systemic
toxicity
ISO 10993-23 : 2021
Biological evaluation of
medical devices Part 23:
Tests for skin irritation	The test item was evaluated
for skin irritation using in vitro
reconstructed human
epidermis model EpiDerm
Skin Irritation Test	Under the
conditions of the
study, no skin
irritation	Under the
conditions of the
study, no skin
irritation

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.