Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the summary describes standard physical and chemical property testing, with no mention of AI or ML.

Therapeutic

No
The device is a glove for preventing contamination, not for treating any condition or disease.

Diagnostic

No
The device, nitrile examination gloves, is intended to prevent contamination between the patient and examiner, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile examination gloves) and the summary describes physical properties and performance tests related to the material and construction of the gloves, not software functionality.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between the patient and examiner." This is a barrier function, not a diagnostic test performed on samples taken from the body.
Device Description: The description focuses on the physical properties and standards for examination gloves, not on any reagents, instruments, or procedures used for in vitro testing.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Using reagents or specialized equipment for testing

The device is a medical examination glove, which is a Class I or Class II medical device depending on its intended use and classification by regulatory bodies, but it is not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This is a disposable device intended for medical purposes: that is worn on the examiner hand, to prevent contamination between the patient and examiner.

The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

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

LZA

Device Description

Powder-Free Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Performance data of gloves based on ASTM D6319-00a. ASTM D6319-00a Section 9 is inapplicable for non-sterile examination grade nitrile gloves.

Test	ASTM 6319-00a	Powder-Free Nitrile Examination Gloves
1. Detection of Holes (ASTM 5151)	Multiple Normal G1 AQL = 2.5	Pass G1 AQL = 2.5*
2. Length (mm) Size XS S M L XL	Min 220 - Min 220 - Min 230 - Min 230 - Min 230	240 mm minimum for all sizes*
3. Palm Width (mm) Size XS S M L XL	70+ 10 80+ 10 95+ 10 111+ 10 120 + 10	73-78 83-88 93-98 103-107 110 - 118*
4. Thickness (mm) Finger Palm	Min 0.05 Min 0.05	Min 0.06 Min 0.05*
5. Physical Properties Before Aging Tensile Strength (Mpa) Ultimate Elongation (%) After Aging Tensile Strength (Mpa) Ultimate Elongation (%)	Min 14 Min 500 Min 14 Min 400	15 - 21 550 - 630* 14 - 22 520 - 610*
6. Powder Content	Max 2.0mg/glove	Below 2.0mg/glove
7. Primary Skin Irritation CPSC Title 16 Chapter II Part 1500	PII Greater or equal to 5.0 indicates an irritate	PII was "0.04"*
8. Dermal Sensitization Test ISO 10993-10	Score greater or equal to 1 indicates irritation/hypersensitivity	Score was "0"*

*Third Party test data is available in Appendix A

The performance data of the gloves as shown above meet the ASTM D6319-00a Standard using the following test methods:

ASTM D412 Tensile Properties Unaged Test Method A ●
ASTM D573 Tensile Properties Aged .
ASTM D5151 Detection of Holes .
ASTM D6124-06 Section 7 Procedure I for Powder-free Gloves .
1. The Biocompatibility Test consists of Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) and Dermal Sensitization Tests (ISO 10993-10).

*Third Party test data is available in Amendment F

The conclusion of the Biocompatibility Testing would indicate that there is no irritation or hypersensitivity to the subject gloves (NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves in the color blue).

It is concluded that the NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves in the color blue for this submission meets ASTM D6319-00a, CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements.

The gloves tested in the Biocompatibility Testing were the subject glove (NitriTech®, Non-Sterile Powdered Nitrile Examination Gloves in the color blue) of this submission. Mediamal Testing and Consultancy Services had the Primary Skin Irritation (study report # MB-PSI-27-09) and Dermal Sensitization Test (study report # MB-DSAb-27-09) completed to CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 standards.

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.

K090828

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

0

510K Summary

. / -

ﺴ

510K: 093517

1. Information
	Submitter's
	Name:	Summit Glove Inc.
	Address:	310 South Grant Street
		Minerva, Ohio 44657
	Phone:	330-868-0066
	Contact Person:	James Moore
	E-mail:	jmoore@summitglove.com
2. Name of Device
	Trade or Proprietary Name:	NitriTech®, Non-Sterile Powder-Free Nitrile
Examination Glove in the color blue
	Common or Usual Name:	Synthetic Rubber Examination Gloves
	Classification Name:	Patient Examination Glove, Powder-Free
3. Predicate Device:
	Non-Sterile Nitrile Powder-Free Medical Examination
Gloves Submission Number: K090828. Based on the below
test results, it is concluded the subject gloves are a
substantial equivalent to the predicate device.

4. Identification of the Legally Marketed Devices

Powder-Free Nitrile Examination Gloves as described in this 510K Notification is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D6319-00a, Standard for Nitrile Gloves for Medical Application.

5. Description of Device

Powder-Free Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

6. Intended Use of Gloves

This is a disposable device intended for medical purposes: that is worn on the examiner hand, to prevent contamination between the patient and examiner.

1

7. Summary of Performance Data:

Performance data of gloves based on ASTM D6319-00a. ASTM D6319-00a Section 9 is inapplicable for non-sterile examination grade nitrile gloves.

| Test | ASTM 6319-00a | Powder-Free Nitrile
Examination Gloves |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|
| 1. Detection of Holes (ASTM
5151) | Multiple Normal
G1
AQL = 2.5 | Pass G1 AQL = 2.5* |
| 2. Length (mm)
Size XS
S
M
L
XL | Min 220 -
Min 220 -
Min 230 -
Min 230 -
Min 230 | 240 mm minimum for all
sizes* |
| 3. Palm Width (mm)
Size XS
S
M
L
XL | 70+ 10
80+ 10
95+ 10
111+ 10
120 + 10 | 73-78
83-88
93-98
103-107
110 - 118* |
| 4. Thickness (mm)
Finger
Palm | Min 0.05
Min 0.05 | Min 0.06
Min 0.05* |
| 5. Physical Properties
Before Aging
Tensile Strength (Mpa)
Ultimate Elongation (%)
After Aging
Tensile Strength (Mpa)
Ultimate Elongation (%) | Min 14
Min 500
Min 14
Min 400 | 15 - 21
550 - 630*
14 - 22
520 - 610* |
| 6. Powder Content | Max 2.0mg/glove | Below 2.0mg/glove |
| 7. Primary Skin Irritation CPSC
Title 16 Chapter II Part 1500 | PII Greater or equal to 5.0
indicates an irritate | PII was "0.04"* |
| 8. Dermal Sensitization Test ISO
10993-10 | Score greater or equal to 1
indicates
irritation/hypersensitivity | Score was "0"* |

*Third Party test data is available in Appendix A

The performance data of the gloves as shown above meet the ASTM D6319-00a Standard using the following test methods:

2

ASTM D412 Tensile Properties Unaged Test Method A ●
ASTM D573 Tensile Properties Aged .
ASTM D5151 Detection of Holes .
ASTM D6124-06 Section 7 Procedure I for Powder-free Gloves .
1. The Biocompatibility Test consists of Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) and Dermal Sensitization Tests (ISO 10993-10).

*Third Party test data is available in Amendment F

The conclusion of the Biocompatibility Testing would indicate that there is no irritation or hypersensitivity to the subject gloves (NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves in the color blue).

9. Conclusion:

It is concluded that the NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves in the color blue for this submission meets ASTM D6319-00a, CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements.

3

Statement concerning the Biocompatibility Testing

The gloves tested in the Biocompatibility Testing were the subject glove (NitriTech®, Non-Sterile Powdered Nitrile Examination Gloves in the color blue) of this submission. Mediamal Testing and Consultancy Services had the Primary Skin Irritation (study report # MB-PSI-27-09) and Dermal Sensitization Test (study report # MB-DSAb-27-09) completed to CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 standards.

18

4

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 9 2010

Mr. James Moore Project Coordinator Summit Glove, Incorporated 310 South Grant Street Minerva, Ohio 44657

Re: K093517

Trade/Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 10, 2010 Received: June 15, 2010

Dear Mr. Moore:

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. 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.

5

Page 2- Mr. Moore

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 reportung (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

f

Sincerely yours

Susan Runner

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

6

Indications for Use

510(k) Number (if known): K093517

Device Name: NitriTech® Non-Sterile Powder Free Nitrile Medical Examination Gloves in the color blue.

Indications For Use:

The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division-Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K093517 510(k) Number: _______________________________________________________________________________________________________________________________________________________________