← Product Code [LZA](/productcode/LZA) · K162146
# Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) (K162146)
_Brightway Holdings Sdn. Bhd. · LZA · Jan 5, 2017 · General Hospital · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K162146
## Device Facts
- **Applicant:** Brightway Holdings Sdn. Bhd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jan 5, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital
## Indications for Use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.
## Device Story
Disposable nitrile examination glove; provides barrier protection for examiner's hands; prevents cross-contamination between patient and examiner. Used in clinical settings by healthcare professionals. Device is non-sterile, powder-free, and lavender-colored. Performance verified through tensile strength, elongation, and water-tight testing per ASTM standards. Benefits include reliable barrier protection during medical examinations.
## Clinical Evidence
Bench testing only. Testing included physical property analysis (tensile strength, elongation, modulus), water-tight testing (ASTM D5151), residual powder testing (ASTM D6124), and biocompatibility (ISO 10993-10 for irritation/sensitization and ISO 10993-11 for systemic toxicity). Results confirmed the device is non-sensitizing, non-irritating, and non-systemically toxic, meeting all ASTM D6319-10 specifications.
## Technological Characteristics
Nitrile compound barrier film; powder-free; non-sterile. Dimensions and physical properties comply with ASTM D6319-10. Biocompatibility per ISO 10993-10 and ISO 10993-11. Manufactured in ISO 9001:2008 and ISO 13485:2003/EN ISO 13485:2012 certified facilities.
## Regulatory 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.
## Predicate Devices
- KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves ([K081260](/device/K081260.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Brightway Holdings Sdn Bhd. Dr. G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, 42100 MY
Re: K162146
Trade/Device Name: Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: July 19, 2016 Received: August 1, 2016
Dear Dr. 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
{1}------------------------------------------------
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.
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.
Sincerelv.
# 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
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#### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162146
Device Name
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER]
Indications for Use (Describe)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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## 510(K) SUMMARY
## BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER]
- 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 |
- 4th January 2017 2. Preparation Date :
- 3. Name of the Device :
Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER]
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Device Classification Name: Patient Examination Glove
### (21 CFR 880.6250)
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:
- 1) K081260 KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves
#### 5. Device Description :
The subject device in this 510(k) Notification is a Lavender Examination Glove.
The subject device is a patient examination glove made from a Nitrile compound, Lavender 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, [LAVENDER] 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 Dimension Measurement & Water Tight Test Report
Certificate No : 6G11 01
Date : 11/07/2016
: Lavender Nitrile Exam Glove. Brand
Prd Description : Brightway Brand Nitrile Examination Gloves, Powder Free [Lavender]
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 Sumpling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2
Batch No: 6G02 01
| Sample No. | Size | Weight (g) | Length (mm) | Width (mm) | Thickness (mm) | | |
|---------------------------|------|----------------|-------------------------------------|-------------------------------------|----------------------------------------|----------------------------------------|----------------------------------------|
| | | | | | Finger Tip | Palm | Cuff |
| 1 | XS | 2.8 | 243 | 78 | 0.095 | 0.065 | 0.055 |
| 2 | XS | 2.7 | 240 | 77 | 0.090 | 0.070 | 0.055 |
| 3 | XS | 2.8 | 243 | 78 | 0.090 | 0.075 | 0.06 |
| 4 | XS | 2.9 | 242 | 77 | 0.095 | 0.065 | 0.055 |
| 5 | S | 3.1 | 243 | 84 | 0.090 | 0.070 | 0.055 |
| 6 | S | 3.0 | 241 | 85 | 0.095 | 0.070 | 0.06 |
| 7 | S | 3.0 | 242 | 83 | 0.090 | 0.075 | 0.055 |
| 8 | S | 2.9 | 243 | 84 | 0.095 | 0.065 | 0.06 |
| 9 | M | 3.1 | 241 | 97 | 0.095 | 0.065 | 0.065 |
| 10 | M | 3.3 | 242 | 98 | 0.10 | 0.070 | 0.06 |
| 11 | M | 3.2 | 242 | 97 | 0.095 | 0.070 | 0.055 |
| 12 | M | 3.1 | 243 | 98 | 0.095 | 0.075 | 0.06 |
| 13 | L | 3.9 | 243 | 114 | 0.090 | 0.065 | 0.065 |
| 14 | L | 3.8 | 241 | 112 | 0.10 | 0.070 | 0.055 |
| 15 | L | 3.7 | 242 | 112 | 0.095 | 0.075 | 0.06 |
| 16 | L | 3.8 | 243 | 113 | 0.095 | 0.070 | 0.055 |
| 17 | XL | 4.1 | 242 | 121 | 0.090 | 0.065 | 0.055 |
| 18 | XL | 4.0 | 241 | 120 | 0.090 | 0.070 | 0.06 |
| 19 | XL | 4.0 | 242 | 121 | 0.095 | 0.075 | 0.06 |
| 20 | XL | 4.1 | 243 | 120 | 0.090 | 0.070 | 0.06 |
| Specification For XS | | $2.7 \pm 0.3g$ | Min - 230
Tar - 240
Max - 258 | Min - 60
Tar - 70
Max - 80 | Min - 0.06
Tar - 0.08
Max - 0.11 | Min - 0.05
Tar - 0.07
Max - 0.09 | Min - 0.05
Tar - 0.06
Max - 0.08 |
| Specification For Small | | $2.9 \pm 0.3g$ | Min - 230
Tar - 240
Max - 258 | Min - 70
Tar - 80
Max - 90 | Min - 0.06
Tar - 0.08
Max - 0.11 | Min - 0.05
Tar - 0.07
Max - 0.09 | Min - 0.05
Tar - 0.06
Max - 0.08 |
| Specification For Medium | | $3.2 \pm 0.3g$ | Min - 230
Tar - 240
Max - 258 | Min - 85
Tar - 95
Max - 105 | Min - 0.06
Tar - 0.08
Max - 0.11 | Min - 0.05
Tar - 0.07
Max - 0.09 | Min - 0.05
Tar - 0.06
Max - 0.08 |
| Specification For Large | | $3.8 \pm 0.3g$ | Min - 230
Tar - 240
Max - 258 | Min - 100
Tar - 110
Max - 120 | Min - 0.06
Tar - 0.08
Max - 0.11 | Min - 0.05
Tar - 0.07
Max - 0.09 | Min - 0.05
Tar - 0.06
Max - 0.08 |
| Specification For XL | | $4.0 \pm 0.3g$ | Min - 230
Tar - 240
Max - 258 | Min - 110
Tar - 120
Max - 130 | Min - 0.06
Tar - 0.08
Max - 0.11 | Min - 0.05
Tar - 0.07
Max - 0.09 | Min - 0.05
Tar - 0.06
Max - 0.08 |
| Number of non-conformance | | 0 | 0 | 0 | 0 | 0 | 0 |
| Status | | Pass | Pass | Pass | Pass | Pass | Pass |
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## 7.2. Gloves Physical Properties and Freedom From Holes
#### Water-tight Test
Test method: ASTM D5151
Sample tested: 200 pieces per Batch.
Random Sampling based on 1502859-1:1999; G2 AQL 1.5, Ac=7 Rej=8
| Location of holes | Size : X - Small | Size : Small | Size : Medium | Size : Large | Size : X - Large |
|-----------------------|------------------|--------------|---------------|--------------|------------------|
| Cuff | 0 | 0 | 1 | 0 | 0 |
| Palm | 2 | 0 | 0 | 0 | 0 |
| Finger-tip | 0 | 0 | 0 | 0 | 0 |
| Total defective Found | 1 | | | | |
| Acceptance number | 7 | | | | |
| Status | Pass | | | | |
#### BRIGHTWAY HOLDINGS SDN BF
Testing Services
Physical Properties Analysis Report
| Certificate No | : | 6G11 25 | Date : 11/07/2016 |
|-----------------------|---|-----------------------------------------------------------------------|-------------------|
| Customer | : | N/A | |
| Brand | : | LAVENDER NITRILE EXAM GLOVES | |
| PO No | : | N/A | |
| PI No | : | N/A | |
| Batch No | : | 6G02 01 | |
| Product Description | : | Brightway Brand Nitrile Examination Gloves, Powder Free
[Lavender] | |
| Sample Receiving Date | : | 03.07.2016 | |
| 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 | : | 10/07/2016 | |
| Aging | : | 70 +/- 2 deg C for 168 Hrs . | |
| Test Environment
Condition | | Room Temperature (°C) : 23
RH (%)
: 48 | | | Room Temperature (°C) : 23
RH (%)
: 48 | |
|-------------------------------|-------------------|----------------------------------------------|------------------------------|-------------------------------|----------------------------------------------|-------------------------------|
| | | Before Aging | | | After Aging | |
| Sample
No | Size | Modulus
At 500%
(MPa) | Tensile
Strength
(MPa) | Ultimate
Elongation
(%) | Tensile
Strength
(MPa) | Ultimate
Elongation
(%) |
| 1 | XS | 18.9 | 26.125 | 592.6 | 27.412 | 510.6 |
| 2 | XS | 19.5 | 27.986 | 561.7 | 26.322 | 529.4 |
| 3 | XS | 17.9 | 29.632 | 578.8 | 25.879 | 492.5 |
| 4 | XS | 18.2 | 26.231 | 592.3 | 27.653 | 503.7 |
| 5 | S | 19.5 | 27.588 | 581.6 | 26.968 | 536.9 |
| 6 | S | 17.4 | 29.451 | 559.2 | 25.121 | 511.6 |
| 7 | S | 18.3 | 28.212 | 563.5 | 27.454 | 507.8 |
| 8 | S | 19.2 | 26.102 | 586.4 | 26.958 | 498.8 |
| 9 | M | 18.9 | 27.877 | 577.3 | 25.525 | 522.9 |
| 10 | M | 17.7 | 29.636 | 591.6 | 24.118 | 537.7 |
| 11 | M | 19.2 | 26.096 | 554.2 | 25.412 | 542.3 |
| 12 | M | 18.9 | 27.741 | 596.8 | 26.589 | 519.2 |
| 13 | L | 17.5 | 26.655 | 583.7 | 26.470 | 507.3 |
| 14 | L | 18.6 | 28.825 | 573.1 | 27.965 | 544.9 |
| 15 | L | 19.4 | 29.821 | 565.8 | 25.231 | 520.5 |
| 16 | L | 17.6 | 26.644 | 680.4 | 26.598 | 518.1 |
| 17 | XL | 18.2 | 27.132 | 593.2 | 27.415 | 502.6 |
| 18 | XL | 19.5 | 29.990 | 570.8 | 24.626 | 533.8 |
| 19 | XL | 19.2 | 26.512 | 588.9 | 26.118 | 510.7 |
| 20 | XL | 18.4 | 27.849 | 591.6 | 25.956 | 546.4 |
| | Average Result | 18.6 | 27.805 | 588.8 | 26.075 | 523.5 |
| | Cust. Requirement | N/A | 16 (Min) | 500 (Min) | 15(Min) | 450 (Min) |
Gloves meet all the specification listed in ASTM D 6319-10
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- 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 non-systemically toxic
Summary of Technical Characteristics and Substantial Equivalence Compared to Predicate Device :
The predicate device in scope is as follows
- 1) K081260 KlMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is substantially equivalent in safety and effectiveness to K081260 -KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves
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:
| Characteristics | Standard | Device Performance | | |
|---------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | | Predicate Device :
K081260 -
Kimberly Clark*
Lavender*
Nitrile Powder
Free
Examination
Glove | Subject Device :
K162146 -
BRIGHTWAY
BRAND NITRILE
EXAMINATION
GLOVES, POWDER
FREE, [LAVENDER] | Result of
Comparison |
| Labeling | N/A | There are no
special labeling
claims and do not
claim gloves as
hypoallergenic on
labels. No shelf life
claim. | There are no special
labeling claims and
do not claim gloves
as hypoallergenic on
labels. No shelf life
claim. | Same |
| Device Materials | N/A | Nitrile Compound | Nitrile Compound | Same |
| Colour | N/A | Lavender | Lavender | Same |
| Device Tolerances and Specifications & Performance Data | | | | |
| Tensile strength:
before and after
ageing | ASTM 6319-10 | Meets
requirements | Meets requirements | Same |
| Ultimate Elongation :
Before and after
ageing | ASTM 6319-10 | Meets
requirements | Meets requirements | Same |
| Freedom from
Pinholes | ASTM 6319-10 | Meets
requirements | Meets requirements | Same |
| Dimensions: | ASTM 6319-10,
ASTM 6319-10 | Meets
requirements | Meets requirements | Same |
| Residual Powder : | ASTM D6124 | Meets
requirements | Meets requirements | Same |
| Biocompatibility | | | | |
| Primary Skin
Irritation test | ISO 10993-10 | Under conditions
of the study, not
an irritant | Under conditions of
the study, not an
irritant | Same |
| Dermal
sensitization assay | ISO 10993-10 | Under conditions
of the study, not a
contact sensitizer | Under conditions of
the study, not a
contact sensitizer | Same |
| Systemic Toxicity | ISO 10993-11 | Non-systemically
toxic | Non-systemically
toxic | Same |
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#### 12.0 Conclusion
Based on intended uses, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is substantially equivalent to the predicate device K081260 - KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves.
Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K081260 - KlMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves
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.
There are no safety/efficacy issues or new claims from the "substantial equivalence comparison" between the products cited.
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.
---
**Source:** [https://fda-staging.innolitics.com/device/K162146](https://fda-staging.innolitics.com/device/K162146)
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