(146 days)
79KGO
Not Found
No
The document describes a standard surgical glove and its performance testing based on physical properties and sterility, with no mention of AI or ML.
No.
A therapeutic device is used to treat or manage a disease or condition, while a surgical glove primarily provides a barrier for protection.
No.
The device is a surgical glove, which is intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device description and performance studies clearly indicate a physical product (surgical gloves) and do not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's described as a Class I Powder free Surgical Glove. Surgical gloves are medical devices used for protection and hygiene, not for diagnosing conditions.
- Lack of IVD Characteristics: The description and performance data focus on physical properties, sterility, and freedom from holes, which are relevant to a protective barrier device. There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
Powder free Surgeon's glove is a Powder free Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
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
Operating room personnel / 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)
The performance test data of the powder free surgical gloves manufactured by Brightway Gloves Pvt.Ltd is given below.
The Powder free Surgeon's gloves manufactured by Brightway Gloves Pvt Ltd
- Meet or exceed the ASTM D3577 -
- Meet FDA Pin hole Requirement. -
- Meet labeling claim as shown by the data in 6
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PHYSICAL PROPERTIES:
Before Ageing:
Tensile Strength: 27 mpa
Elongation at break %: 850%
Modulus at 500 % elongation.: 3 mpa
After Ageing:
Tensile Strength: 20 mpa
Elongation at break %: 750%
PERFORMANCE REQUIREMENT:
Sterility: Fails sterility, As per Indian Pharmacopeias
Freedom from Holes: Holes, S4, AQL 1.5
Dimension: Width, Length, Thickness., S2, AQL 4
Physical Property: Tensile strength, Elongation at break before and after ageing., S2, AQL 4
POWDER CONTENT: 1 +/- 1 mg per Glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.8 % max
BIOCOMPATABILITY: Biologically Compatible
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.
Class I Surgeon's Glove ( Powder free) 79KGOthat meets all the requirements of ASTM D3577.
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
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
MAY 2 2 2002
PAGE NO : 75
- 510K SUMMARY as required by: 807.92(c)
1.0 APPLICANT
BRIGHTWAY GLOVES PVT.LTD NAME : ADDRESS PIONEER MANIKANDAN BUILDINGS, VADASERY NAGAR COIL, TAMIL NADU, INDIA - 629001. PH.NO. 91-4652-276291, 276046. . FAX NO 91-4652-274271 ﻪ
CONTACT PERSON : N. PARAMASIVAN : MANAGING DIRECTOR
:
- DEVICE TRADE NAME : NIL
COMMON NAME : Surgeon's Glove
: Powder free Surgeon's Glove Classification Name
-
- Legally marketed device to which the company claiming equivalence: Class I Surgeon's Glove ( Powder free) 79KGOthat meets all the requirements of ASTM D3577.
5. DESCRIPTION OF THE DEVICE :
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
6.0 Intended use of the Device:
Powder free Surgeon's glove is a Powder free Medical Device intended tobe worn by Operating room personnel to protect a surgical wound from contamination.
Image /page/0/Picture/15 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. Inside the circle, the word "NAGERCOIL" is printed in bold, block letters. A five-pointed star is located at the bottom of the stamp.
1
PAGE NO : 76
7.0 Technological characteristics of the device compared to predicate device.
| Measured Parameters of Latex
Surgeon's gloves (Powder free)
manufactured by Brightway Gloves
Pvt.Ltd | | | ASTM D3577
Requirement for
Latex Surgeon's glove
(Powder free) |
|---------------------------------------------------------------------------------------------------------------|------|------------|-------------------------------------------------------------------------|
| Characteristics | SIZE | Value | |
| 1. Length | 5 ½ | 270-272 mm | 245 mm minimum |
| | 6 | 270-272 mm | 265 mm minimum |
| | 6 ½ | 270-272 mm | 265 mm minimum |
| | 7 | 270-272 mm | 265mm minimum |
| | 7 ½ | 270-272 mm | 265 mm minimum |
| | 8 | 270-272 mm | 265 mm minimum |
| | 8 ½ | 270-272 mm | 265 mm minimum |
| | 9 | 270-272 mm | 265 mm minimum |
| 2. Width | 5 ½ | 68 mm | 70 +/- 6 mm |
| | 6 | 73mm | 76 +/- 6mm |
| | 6 ½ | 79mm | 83 +/- 6 mm |
| | 7 | 87mm | 99 +/- 6 mm |
| | 7 ½ | 92mm | 95 +/- 6 mm |
| | 8 | 103mm | 105+/- 6 mm |
| | 8 ½ | 106mm | 108 +/- 6 mm |
| | 9 | 112mm | 114+/- 6 mm |
-
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
ASTM D3577 requirement for thickness at cuff, palm and finger tip is 0.1 mm minimum.
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0 .16 and 0.19mm.
PHYSICAL PROPERTIES:
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| Characteristics | BGPL Value | ASTM | ||
| D3577 | ||||
| Requirement | BGPL Value | ASTM | ||
| D3577 | ||||
| Requirement | ||||
| Tensile Strength | 27 mpa | 24 mpa | 20 mpa | 18 mpa min |
| Elongation at break % | 850% | 750% | 750% | 560% min |
| Modulus at 500 % | ||||
| elongation. | 3 mpa | 5.5 mpa | ||
| (max) | - | - |
Image /page/1/Picture/7 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge of the circle. In the center of the circle, the word "NAGERCOIL" is printed in bold, block letters. There is a small design at the bottom of the circle.
2
PAGE NO : 77
| PERFORMANCE REQUIREMENT: | |||||
|---|---|---|---|---|---|
| Characteristics | Related defects | Level followed By | Level As per ASTM D 3577 | AQL followed | AQL as per ASTM D3577. |
| BGPL | |||||
| Sterility | Fails sterility | As per IP* | As per USP*. | NA | NA |
| Freedom from Holes | Holes | S4 | S4 | 1.5 | 1.5 |
| Dimension | Width , | ||||
| Length | |||||
| Thickness. | S2 | S2 | 4 | 4 | |
| Physical Property | Tensile strength, | ||||
| Elongation at break before and after ageing. | S2 | S2 | 4 | 4 |
IP — INDIAN PHARMACOPEA
POWDER CONTENT
| BGPL VALUE | ASTM REQUIREMENT |
|---|---|
| Nil Powder | 2 mg/glove max |
PROTEIN CONTENT:
| ARPL VALUE | FDA REQUIREMENT |
|---|---|
| 80 +/- 20 ppm | 200 ppm max. |
MOISTURE CONTENT:
| IDDI | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " |
|---|---|
| TT / Y 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 1207 |
| 9 80%. | value tixed |
| max | All |
BIOCOMPATIBILITY:
| ARPL GLOVE | FDA REQUIREMENT |
|---|---|
| Biologically Compatible | Biologically Compatible |
3
8.0. Performance Data:
The performance test data of the powder free surgical gloves manufactured by Brightway Gloves Pvt.Ltd is given below.
| Measured Parameters of Latex | ||
|---|---|---|
| Surgeon's gloves (Powder free) | ||
| manufactured by Brightway Gloves | ||
| Pvt.Ltd., | ||
| Characteristics | SIZE | Value |
| 1. Length | 5 ½ | 270 – 272 mm |
| 6 | 270 – 272 mm | |
| 6 ½ | 270 – 272 mm | |
| 7 | 270 – 272 mm | |
| 7 ½ | 270 – 272 mm | |
| 8 | 270 – 272 mm | |
| 8 ½ | 270 – 272 mm | |
| 9 | 270 – 272 mm | |
| 2. Width | 5 ½ | 68 mm |
| 6 | 73 mm | |
| 6 ½ | 79 mm | |
| 7 | 87 mm | |
| 7 ½ | 92 mm | |
| 8 | 103 mm | |
| 8 ½ | 106 mm | |
| 9 | 112 mm |
-
- Thickness at cuff , Palm and finger tip of all the size is 0 .12, 0.16 and 0.19 mm.
PHYSICAL PROPERTIES:
| Characteristics | Before Ageing | After Ageing |
|---|---|---|
| Tensile Strength | 27 mpa | 20 mpa |
| Elongation at break % | 850% | 750% |
| Modulus at 500 % | ||
| elongation. | 3 mpa | - |
Image /page/3/Picture/7 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the outer edge of the circle. Inside the circle, the word "NAGERCOIL" is written in bold, block letters. The stamp appears to be black ink on a white background. The image is slightly blurry, but the text is still legible.
4
PAGE NO : 79
PERFORMANCE REQUIREMENT:
| Characteristics | Related
defects | LEVEL | AQL |
|-----------------------|-------------------------------------------------------------------------------|--------------------------------|-----|
| Sterility | Fails sterility | As per Indian
Pharmacopeias | |
| Freedom from
Holes | Holes | S4 | 1.5 |
| Dimension | Width ,
Length
Thickness. | S2 | 4 |
| Physical
Property | Tensile
strength,
Elongation at
break before
and after
ageing. | S2 | 4 |
POWDER CONTENT: 1 + /- 1 mg per Glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: 0.8 % max
BIOCOMPATABILITY: Biologically Compatible
-
Clinical Data NA ・・
-
CONCLUSION OF PERFORMANCE TEST DATA:
The Powder free Surgeon's gloves manufactured by Brightway Gloves Pvt Ltd
- Meet or exceed the ASTM D3577 -
- Meet FDA Pin hole Requirement. -
- Meet labeling claim as shown by the data in 6
11. ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol composed of three curved lines, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
MAY 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. N. Paramasivan Managing Director Brightway Gloves Private Limited Pioneer Manikandan Building Vadasery, Nagar Coil, Tamil Nadu, INDIA
Re: K014283
Trade/Device Name: Sterile Latex Surgeons Glove ( Powder Free ) Regulation Number: 878.4460 Regulation Name: Surgeons Glove Regulatory Class: I Product Code: KGO Dated: March 23, 2002 Received: April 11, 2002
Dear Mr. N. Paramasivan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
6
Page 2 - Mr. N. Paramasivan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
3.0 INDICATIONS FOR USE:
BRIGHTWAY GLOVES PVT.LTD. APPLICANT :
KO14283 510(K) No.
DEVICE NAME
INDICATIONS FOR USE:
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Olin S. Lin
(Division Sign-Off) Division of Oigh-Off)
Division of Dental, Infection Control,
Frid General Hospital Dowis ் General Bental, Infection O
O(k) Number (k) Number
Image /page/7/Picture/9 description: The image shows a circular stamp with the words "HIGHWAY GLOVES PVT. LTD." written around the edge. In the center of the stamp, the word "NAGERCOIL" is written in block letters. The stamp appears to be black and white and has a slightly worn or used look.