(83 days)
80LYY
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or any related technologies.
No.
The device (examination glove) is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is an examination glove, which is intended to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove made of natural latex, clearly described as a disposable hardware device.
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 made of natural latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner". This describes a barrier device used during physical examination, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: It's described as a "Class I Patient Examination Gloves (powdered)". This classification and description align with personal protective equipment used in a medical setting.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The information provided focuses on the physical properties and performance of the glove as a barrier, which is consistent with its intended use as an examination glove.
N/A
Intended Use / Indications for Use
EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE LATEX MEDICAL PURPOSE THAT IS NATURAL LATEX INTENDED FOR MADE OF WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION AND TO PAWDEREA WITH ARSANAAAFF BETWEEN PATIENT AND EXAMINER DUSTING POWDER USP CORN STARCH.
Product codes
LYY
Device Description
Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.
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)
The performance test data of the Latex Examination Glove (powdered) manufactured by Brightway Gloves Pvt.Ltd given below.
Measured Parameters of Examination gloves (powdered) manufactured by Brightway Gloves Pvt. Ltd.,
Characteristics:
- Length: EX-S, S, M, L (235-240 mm for all sizes)
- Width: EX S (70MM), S (82 mm), M (93 mm), L (107 mm)
- Thickness: EX S, S, M, L (0.10mm for all sizes)
Physical Properties:
A 914: 11.02
Elongation at break %: MARKER FREE LE LE LE LEBERT (2000/)
Inspection Level and AQL:
Characteristics / Related defects / Level / AQL
Freedom from Holes / Holes / S4 / 1.5
Dimension / Width, Length Thickness. / S2' / 4
Physical Property / Tensile Strength, Elongation at Break. / S2 / 4
POWDER CONTENT: 120 +/- 20 mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATIBILITY: Biologically Compatible.
Conclusion of Performance Test Data:
The Examination gloves (powdered) manufactured by M/S Brightway Gloves Pvt.Ltd, Meet or exceed the ASTM D3578, Meet FDA Pin hole Requirement, Meet labelling claim as shown by the data in 6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Class I Patient Examination Gloves (powdered) 80LYY
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
PAGE NO: 50
1.0. 510K SUMMARY as required by: 807.92(c)
| 2.0 APPLICANT | K014280 MAR 2 0 2002 |
|---|---|
| NAME | M/s. BRIGHTWAY GLOVES PVT.LTD. |
| ADDRESS | PIONEER MANIKANDAN BUILDINGS VADASERY, NAGERCOIL, TAMILNADU, INDIA-629001. |
| PH.NO. | 91-4652-276046, 276291 |
| FAX NO | 91-4652-274271. |
| CONTACT PERSON | MR. N. PARAMASIVAN MANAGING DIRECTOR. |
| 3. DEVICE TRADE NAME | : NIL |
| COMMON NAME | : Patient Examination Glove (powdered) |
-
- Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves (powdered) 80LYY that meets all the requirements of ASTM D3578 .
5. DESCRIPTION OF THE DEVICE:
Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.
- Intended use of the Device:
Latex Examination glove (powdered) is a disposable device made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner and is powdered with a donning powder absorbable USP corn starch.
Image /page/0/Picture/8 description: The image is a circular seal with the words 'BRIGHTWAY GLOVES PVT. LTD.' around the outer edge. Inside the circle is the word 'NAGERCOIL' in bold, block letters. A five-pointed star is at the bottom of the seal.
1
7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of
Examination gloves (powdered)
manufactured by Brightway Gloves | | | ASTM D3578
Requirement for
Examination glove
(powdered) |
|---------------------------------------------------------------------------------------------|------|------------|------------------------------------------------------------------|
| Characteristics | SIZE | Value | |
| 1. Length | EX-S | 235-240 mm | 220 mm minimum |
| | S | 235-240 mm | 220 mm minimum |
| | M | 235-240 mm | 230 mm minimum |
| | L | 235-240 mm | 230mm minimum |
| 2. Width | EX S | 70MM | 70 +/- 6 mm |
| | S | 82 mm | 80 +/- 6 mm |
| | M | 93 mm | 95 +/- 6 mm |
| | L | 107 mm | 111+/- 6mm |
| 3. Thickness | EX S | 0.10mm | 0.08 mm minimum |
| | S | 0.10mm | 0.08 mm minimum |
| | M | 0.10mm | 0.08 mm minimum |
| | L | 0.10mm | 0.08 mm minimum |
PHYSICAL PROPERTIES
| BEFORE AGEING | AFTER AGEING | |||
|---|---|---|---|---|
| CHARACTERISTICS | BGPL VALUE * | ASTD 3578 | ||
| REQUIREMENT | BGPL VALUE | ASTD 3578 | ||
| Requirement | ||||
| Tensile Strength | 20 - 22 mpa | 14 mpa min | 18 – 20 mpa | 14 mpa min |
| Elongation at break % | 800 - 850% | 700% min | 750-800% | 500% min |
BGPL -- BRIGHTWAY GLOVES PVT.LTD.
and the control of the state
Image /page/1/Picture/6 description: The image shows a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." around the outer edge. In the center of the stamp, the word "NAGERCOIL" is printed. A five-pointed star is located at the bottom of the stamp.
2
PERFORMANCE REQUIREMENT:
| Characteristics | Related defects | Level followed
By | | AQL
followed by
BGPL | AQL Value as
per ASTM
D3578. |
|-----------------------|-------------------------------------------------|----------------------|-------------------------|----------------------------|------------------------------------|
| | | BGPL | As per
ASTM
D3578 | | |
| Freedom from
Holes | Holes | S4 | S4 | 1.5 | 4 |
| Dimension | Width , Length
Thickness. | S2 | S2 | 4 | 4 |
| Physical
Property | Tensile
Strength,
Elongation at
Break. | S2 | S2 | 4 | 4 |
POWDER CONTENT
| .
| DAT TITT | THE THE THE FEATURE FOR |
|---|---|
| 0 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 | |
| CONTRACT |
PROTEIN CONTENT:
| and the was a | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
and the world of the world and
Company and Comments of a minimum of a management of
| ENCRIALLES IN MALER - LE M MIRIR BELLINER IN LUNDER IN LEDERE |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| - |
| 1 00000 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Company of the control of the super a sense and any and any and any and any and the comments of the comments of the comments of the comments of the comments of the comments o |
| 440 00 11 41 11 |
|
MOISTURE CONTENT:
1118 a 11 11 ... .......................................................................................................................................................................... 11
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Party and the
Market Antoner Addresses and Children Children
Case I look of
| .
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and the manage happing, highlined that and any and one programs | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| would the country of the changes to the charges of the children the contribution of the children the first and the children the first and the charges of the children the firs
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Company of Concession Commenss of the dramation of the charges of
College and count of concession of concession of concession of consideration of consideration of |
. BER FARIL BI --------------------------------------------------------------------------------------------------------------------------------------------------------------- | Concession confessional a | |
BIOCOMPATIBLITY:
:11:14:1
| . | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | *** |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| . |
1 | of the collection of the consideration of
A STATUS ALL PROPER SELL MOLEL PROPERTY CONSULT CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSU |
3
8.0 Performance Data:
The performance test data of the Latex Examination Glove (powdered) manufactured by Brightway Gloves Pvt.Ltd given below.
| Measured Parameters of
Examination gloves (powdered)
manufactured by Brightway Gloves Pvt.
| Ltd., | ||
|---|---|---|
| Characteristics | SIZE | Value |
| 1. Length | EX-S | 235-240 mm |
| S | 235-240 mm | |
| M | 235-240 mm | |
| L | 235-240 mm | |
| 2. Width | EX S | 70MM |
| S | 82 mm | |
| M | 93 mm | |
| L | 107 mm | |
| 3. Thickness | EX S | 0.10mm |
| S | 0.10mm | |
| M | 0.10mm | |
| L | 0.10mm |
PHYSICAL PROPERTIES
| DICITICA | ||
|---|---|---|
| A 914 | 11.02 | |
| Elongation at break % | MARKER FREE LE LE LE LEBERT -------------------------------------------------------------------------------------------------------------------------------------------------- | 2000/ |
INSPECTION LEVEL AND AQL:
| Characteristics | Related defects | Level | AQL |
|---|---|---|---|
| Freedom from | |||
| Holes | Holes | S4 | 1.5 |
| Dimension | Width , Length | ||
| Thickness. | S2' | 4 | |
| Physical | |||
| Property | Tensile | ||
| Strength, | |||
| Elongation at | |||
| Break. | S2 | 4 |
Image /page/3/Picture/8 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the border of the circle. Inside the circle, the word "NAGERCOIL" is written in bold letters. A five-pointed star is located at the bottom of the circle.
4
POWDER CONTENT: 120 +/- 20 mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: .0.8% max
BIOCOMPATIBILITY: Biologically Compatible.
- Clinical Data : NA
CONCLUSION OF PERFORMANCE TEST DATA: 10.
The Examination gloves (powdered) manufactured by M/S Brightway Gloves Pvt.Ltd,
. . Meet or exceed the ASTM D3578
- Meet FDA Pin hole Requirement. -
- Meet labelling 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
Mr. N. Paramasivan Managing Director Brightway Gloves PVT. LTD. Pioneer Manikandan Building Vadasery, Nagar Coil, Tamil Nadu, INDIA
Re: K014280
Trade/Device Name: Latex Examination Gloves (Powdered) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: December 27, 2001 Received: December 27, 2001
Dear Mr. 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. 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
DUPLICATE
K 014280/A'
Page ol
510(k) NUMBER (IF KNOWN0014280 (
DEVICE NAME LATEX-EXANTHATION GLOVES (FOMDERED)
INDICATIONS FOR USE:
EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE LATEX MEDICAL PURPOSE THAT IS NATURAL LATEX INTENDED FOR MADE OF WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION AND TO PAWDEREA WITH ARSANAAAFF BETWEEN PATIENT AND EXAMINER DUSTING POWDER USP CORN STARCH.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter-Use (Optional Format 1-2-96)
Chiu S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _