Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary does not mention any AI/ML capabilities or related technologies.

Therapeutic

No.
The device, a nitrile examination glove, is intended to prevent contamination between the patient and the examiner, acting as a barrier rather than providing any therapeutic effect.

Diagnostic

No

Explanation: The device is a nitrile examination glove intended as a barrier to prevent contamination, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical examination glove made from a Nitrile compound, which is a hardware component. The performance studies and key metrics also relate to the physical properties of the glove.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner." This describes a barrier device for personal protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties and barrier function of the glove. There is no mention of any components or functions related to analyzing biological samples.
Lack of IVD-specific information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims
- Reagents or assays

The device is a medical device, specifically a patient examination glove, but it falls under a different regulatory classification than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE) is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.

Product codes

LZA

Device Description

The subject device in this 510(k) Notification is a Blue Examination Glove.

The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.

This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath

The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012; Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand or finger

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)

Testing was performed per ASTM D6319-10, ASTM D5151-06, ASTM D6124- 06,ISO 10993-10:2010 and 16 CFR Part 1500.41. The glove meet standards requirement referenced in section 6.0 above.

Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and did not reveal any systemic toxicity.

Dimension Measurement:
Test Method: ASTM D6319-10
Sample tested: 20 pieces per Batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2.
Results: All samples passed dimensional specifications.

Water-tight Test:
Test method: ASTM D5151-06
Sample tested: 200 pieces per Batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.0, Ac=5 Rej=6.
Results: 1 total defective found, acceptance number 5. Status: Pass.

Physical Properties Analysis Report (Tensile Strength, Ultimate Elongation):
Test Method: ASTM D 6319 - 10
Sampling Plan: Single Normal S2 AQL: 2.5 Acc/Rej : 1/2.
Sizes Comprising Of: XS, S, M, L & XL
Results:

Before Aging: Average Tensile Strength 24.351 MPa (Customer Requirement 14 (Min)), Average Ultimate Elongation 550.6% (Customer Requirement 500 (Min)).
After Aging: Average Tensile Strength 22.134 MPa (Customer Requirement 14 (Min)), Average Ultimate Elongation 484.5% (Customer Requirement 400 (Min)).
Gloves meet all the specification listed in ASTM D 6319-10.

Biocompatibility:

Primary Skin Irritation test (ISO 10993-10): Under conditions of the study, not an irritant.
Dermal sensitization assay (ISO 10993-10): Under conditions of the study, not a sensitizer.

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

Not Found

Predicate Device(s)

K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

March 24, 2017

Brightway Holdings Sdn Bhd G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, 42100 MY

Re: K163267

Trade/Device Name: Brightway Nitrile Examination Glove, powder free (blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: November 7, 2016 Received: November 21, 2016

Dear G. Baskaran:

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.

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 (reporting of medical devicerelated 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.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K163267

Device Name BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE)

Indications for Use (Describe)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE) is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.

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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3

510(K) SUMMARY

K163267

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE]

1. Submitter :

Company Name :	BRIGHTWAY HOLDINGS SDN. BHD.
Street Address :	Lot 1559, Jalan Istimewa,
	Batu Belah, 42100 Klang
	Selangor Darul Ehsan.
Country :	Malaysia
Phone No. :	603-3343 1007 & 603-3343 1094.
Fax No. :	603-3341 4800
E-mail Address :	brightway@brightway919.com
Contact Person :	Mr. G. Baskaran (Group Managing Director)
	baskar@brightway919.com
	Mr. Felix Darrel (Group Marketing Manager)
	felix.marketing@brightway919.com

18th March 2017 2. Preparation Date :
1. Name of the Device :

Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE]

4

Device Classification Name: Polymer Patient Examination Glove

(21 CFR 88.6250)

Device common or usual name : NITRILE EXAMINATION GLOVE

FDA Device Class : Class 1

Product Code : LZA

4. Identification of the Device :

Class I patient Examination Nitrile gloves, Powder Free, LZA, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.

Predicate Device:

Legally Marketed Devices to which Substantial Equivalence is claimed ; K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color

5. Device Description :

The subject device in this 510(k) Notification is a Blue Examination Glove.

The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.

This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath

The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012; Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves

5

6. Intended use of the Device

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

7. Specification For Nitrile gloves

7.1. Dimension and Thickness of Gloves

Certificate No : 6H22 06

Date : 22/08/2016

Brand : 9.5" Textured Non Sterile Blue Nitrile Exam Gloves.

Prd Description : Brightway Brand Textured Non Sterile Nitrile Examination Gloves, Powder Free (Blue)

Standard Specification for Nitrile Examination Gloves for Medical Application Test Method: ASTM D6319-10

Dimension Measurement

Test Method: ASTM D6319-10 Sample tested: 20 pieces per Batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2

Batch No: 6H10 03

Sample No.	Size	Weight (g)	Length (mm)	Width (mm)	Thickness (mm)
1	XS	4.5	240	75	0.16	0.13	0.085
2	XS	4.6	241	76	0.155	0.125	0.09
3	XS	4.6	241	76	0.16	0.13	0.085
4	XS	4.5	240	78	0.165	0.12	0.095
5	S	5.3	242	87	0.155	0.125	0.085
6	S	5.2	239	87	0.155	0.13	0.09
7	S	5.4	242	87	0.165	0.13	0.085
8	S	5.3	242	86	0.155	0.125	0.095
9	M	6.0	240	97	0.16	0.13	0.085
10	M	6.1	239	96	0.155	0.125	0.09
11	M	5.9	241	96	0.16	0.125	0.085
12	M	6.1	240	97	0.165	0.13	0.095
13	L	7.2	240	115	0.155	0.12	0.085
14	L	7.1	241	116	0.16	0.125	0.09
15	L	7.0	241	117	0.165	0.13	0.08
16	L	7.2	240	115	0.155	0.125	0.095
17	XL	7.3	240	122	0.165	0.125	0.085
18	XL	7.4	239	121	0.155	0.12	0.085
19	XL	7.2	242	120	0.16	0.13	0.09
20	XL	7.3	241	122	0.155	0.12	0.095
Specification For XS
4.6 ± 0.3g		Min - 230
Tar - 242
Max - 258	Min - 60
Tar - 70
Max - 80	Min - 0.12
Tar - 0.15
Max - 0.19	Min - 0.08
Tar - 0.12
Max - 0.16	Min - 0.06
Tar - 0.09
Max - 0.13
Specification For Small
5.2 ± 0.3g		Min - 230
Tar - 242
Max - 258	Min - 70
Tar - 80
Max - 90.	Min - 0.12
Tar - 0.15
Max - 0.19	Min - 0.08
Tar - 0.12
Max - 0.16	Min - 0.06
Tar - 0.09
Max - 0.13
Specification For Medium
6.1 ± 0.3g		Min - 230
Tar - 242
Max - 258	Min - 85
Tar - 95
Max - 105	Min - 0.12
Tar - 0.15
Max - 0.19	Min - 0.08
Tar - 0.12
Max - 0.16	Min - 0.06
Tar - 0.09
Max - 0.13
Specification For Large
7.0 ± 0.3g		Min - 230
Tar - 242
Max - 258	Min - 100
Tar - 110
Max - 120	Min - 0.12
Tar - 0.15
Max - 0.19	Min - 0.08
Tar - 0.12
Max - 0.16	Min - 0.06
Tar - 0.09
Max - 0.13
Specification For XL
7.2 ± 0.3g		Min - 230
Tar - 242
Max - 258	Min - 110
Tar - 120
Max - 130	Min - 0.12
Tar - 0.15
Max - 0.19	Min - 0.08
Tar - 0.12
Max - 0.16	Min - 0.06
Tar - 0.09
Max - 0.13
Number of non-conformance		0	0	0	0	0
Status		Pass	Pass	Pass	Pass	Pass

3

6

7.2. Gloves Physical Properties and Freedom From Holes

Water-tight Test

Test method: ASTM D5151- 06
Sample tested: 200 pieces per Batch.
Random Sampling based on ISO2859-1:1999; G2 AQL 1.0, Ac=5 Rej=6

Location of holes	Size : X - Small	Size : Small	Size : Medium	Size : Large	Size : X - Large
Cuff	0	0	0	0	0
Palm	0	1	0	0	0
Finger-tip	0	0	0	0	0
Total defective Found	1
Acceptance number	5
Status	Pass

BRIGHTWAY HOLDINGS SDN BHD Testing Services Physical Properties Analysis Report

Certificate No	:	6H22 168
Customer	:	N/A
Brand	:	9.5"Textured Non Sterile Blue Nitrile Exam Glove.
PO No	:	N/A
PI No	:	N/A
Batch No	:	6H10 03
Product Description	:	Brightway Brand Textured Non Sterile Nitrile Examination Glove, Powder Free [Blue]
Sample Receiving Date	:	14.08.2016
Sampling Plan	:	Single Normal S2 AQL: 2.5 Acc/Rej : 1/2 .
Sizes Comprising Of	:	XS, S, M, L & XL
Test Method	:	ASTM D 6319 - 10
Test Conducted on	:	21/08/2016
Aging	:	70 +/- 2 deg C for 168 Hrs .

| Test Environment
Condition | RH (%) : 48 | RH (%) : 48 | |-------------------------------|-- | Sample
No | Size | | At 500%
( MPa ) | Tensile
Strength
( MPa ) | Ultimate
Elongation
(%) | Tensile
Strength
( MPa ) | Ultimate
Elongation
(%) |
| 1 | XS | 2 | XS | 3 | XS | 4 | XS | 5 | S | 6 | S | 7 | S | 8 | S | 9 | M | 10 | M | 11 | M | 12 | M | 13 | L | 14 | L | 15 | L | 16 | L | 17 | XL | 18 | XL | 19 | XL | 20 | XL | | | Room Temperature (°C) : 23
| | Room Temperature (°C) : 23
|
-----------------|-------------------------------------------|--------------------------------|-------------------------------|-------------------------------------------|-------------------------------|
| Before Aging | | | After Aging | |
| Modulus
| 16.5 | 23.546 | 575.0 | 21.155 | 495.5 |
| 18.2 | 24.852 | 546.2 | 22.459 | 481.2 |
| 17.4 | 24.865 | 537.8 | 21.398 | 477.2 |
| 19.3 | 23.654 | 562.3 | 23.546 | 499.3 |
| 16.5 | 24.784 | 543.7 | 21.654 | 487.7 |
| 18.4 | 23.123 | 569.5 | 22.478 | 454.0 |
| 17.7 | 23.321 | 544.4 | 21.398 | 451.2 |
| 18.6 | 24.512 | 562.3 | 23.485 | 486.8 |
| 17.4 | 25.845 | 543.7 | 21.145 | 495.6 |
| 19.4 | 24.956 | 569.5 | 22.409 | 485.5 |
| 16.9 | 23.698 | 544.4 | 21.545 | 479.6 |
| 17.6 | 24.654 | 575.4 | 23.348 | 496.5 |
| 18.2 | 25.415 | 568.7 | 21.145 | 492.9 |
| 17.8 | 23.154 | 522.2 | 22.365 | 457.3 |
| 16.3 | 24.856 | 519.4 | 21.398 | 489.3 |
| 18.7 | 23.156 | 530.5 | 23.348 | 487.7 |
| 18.5 | 25.852 | 517.0 | 21.145 | 496.9 |
| 17.8 | 23.465 | 596.0 | 22.409 | 498.5 |
| 16.9 | 25.865 | 543.1 | 21.478 | 488.5 |
| 17.8 | 23.456 | 541.8 | 23.369 | 489.7 |
| Average Result | 17.8 | 24.351 | 550.6 | 22.134 | 484.5 |
| Cust. Requirement | N/A | 14 (Min) | 500 (Min) | 14(Min) | 400 (Min) |

Gloves meet all the specification listed in ASTM D 6319-10

7

8. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data

Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124- 06,ISO 10993-10:2010 and 16 CFR Part 1500.41. The glove meet standards requirement referenced in section 6.0 above.

Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and did not reveal any systemic toxicity

Summary of Technical Characteristics and Substantial Equivalence Comparison Table 9.

The predicate device in scope is as follows:

1. K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color
  BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is substantially equivalent in safety and effectiveness to K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color.

The subject device and predicate device use a similar Nitrile barrier film to achieve a device for the intended use. The properties between the subject device and the predicate device are compared in the following table:

		Device Performance
		Predicate
Device:
K143477- Nitrile
Patient
Examination
Gloves,
Powderfree,
Blue Color	Subject Device :
K161215 -
BRIGHTWAY
BRAND NITRILE
EXAMINATION
GLOVES,
POWDER FREE,
[BLUE]
Characteristics	Standard			Result of
Comparison
Labeling	N/A	There are no
special labeling
claims and do not
claim gloves as
hypoallergenic on
labels.	There are no
special labeling
claims and do not
claim gloves as
hypoallergenic on
labels.	Same
Device Materials	N/A	Nitrile Compound	Nitrile Compound	Same

8

| Device Description | The subject device
in this 510(k)
Notification is a
Blue Examination
Glove.

The subject device
is a patient
examination glove
made from a Nitrile
compound, Blue in
colour, powder free
and non sterile (as
per 21 CFR
880.6250, class I).

The principle
operation of the
medical device to
provide single use
barrier protection | The subject device is
a patient
examination glove
made of synthetic
nitrile latex
compound. It is non-
sterile, powderfree
and is Blue in color.
The device is
ambidextrous and
can be worn on
either the left or
right hand. The
device meets ASTM
06319-10: Standard
specification for
Nitrile Examination
Gloves for Medical
Application. The
subject device is
substantially
equivalent to legally
marketed Nitrile
examination gloves
identified as Product
code LZA. The device
is for over-the
counter single use. | for the wearer and
the device that
meets all the
requirement
specifications for
Barrier Protection,
tensile properties as
defined in ASTM
D6319-10 ;
Standard
specification for
Nitrile Examination
Gloves.

This device is
manufactured in
facilities compliant
to ISO 9001:2008
certified in
Manufacture of Non
Sterile Natural
(Latex) and
Synthetic Latex
(Nitrile)
Examination |

--------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

9

| | | | Surgical and
Industrial Gloves &
Nitrile Sheath

The device is
manufactured to
comply with ISO
13485:2003 / EN
ISO 13485:2012;
Manufacture of Non
Sterile Natural
(Latex) and
Synthetic Latex
(Nitrile)
Examination &
Sterile Surgical
Gloves | |
|---------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | | The Nitrile Patient
Examination
gloves,
Powderfree, Blue
color, is a
disposable device
intended for
medical purposes
that is worn on the
examiners' handprevent
contamination
between patient
and examiner | BRIGHTWAY
BRAND NITRILE
EXAMINATION
GLOVES, POWDER
FREE, [BLUE] is a
disposable device
intended for
medical purpose,
to be worn on the
examiners hand
or finger to
prevent
contamination
between patient
and examiner. | Same |
| Indications for use | N/A | | | |
| Color | N/A | Blue | Blue | Same |
| Device Tolerances and Specifications & Performance Data | | | | |
| Tensile strength :

10

11

10.0 Conclusion

Based on intended uses, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is substantially equivalent to the predicate device K143477- Nitrile Patient Examination Gloves, Powder Free, Blue Color

The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR references, and meets FDA recognized standards for physical properties requirements, pinhole requirements, biocompatibility requirements which are as shown and discussed above.

Based on the complete list of non-clinical tests, the subject device herein mentioned, is as safe, as effective, and performs as well as the legally marketed predicate devices.