(83 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical properties and material standards of examination gloves, with no mention of AI or ML.
No.
The document describes examination gloves, which are used for protection and hygiene during examinations, not for treating a disease or condition.
No
The device is described as an "EXAMINATION GLOVES POWDER FREE." Its intended use is for protection during examinations, not for diagnosing a condition or disease. The performance studies and key metrics listed relate to the physical properties and safety of the glove, not its ability to detect or identify medical conditions.
No
The device description clearly states it is a physical product made of latex (examination gloves) and lists physical performance metrics, not software-related ones.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an "EXAMINATION GLOVES POWDER FREE... intended for medical purpose that is worn on the examiners hand". Its purpose is to provide a barrier between the examiner and the patient, not to analyze a sample from the patient's body.
- Lack of Diagnostic Testing: The "Summary of Performance Studies" lists parameters like length, width, thickness, tensile strength, and freedom from holes. These are all related to the physical properties and integrity of the glove, not to the detection or measurement of substances or conditions within a biological sample.
Therefore, based on the provided information, this device is a medical device used for barrier protection during examinations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Latex Examination Glove (Powder free) is a Powder free devices made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
Class I Patient Examination Gloves Latex (Powder free) 80L Y Y 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 (medical purpose)
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 Latex Examination gloves Powder free manufactured by M/S Brightway Gloves Pvt.Ltd. meet or exceed the ASTM D3578, meet FDA Pin hole Requirement, and meet labelling claim as shown by the data.
Performance test data includes:
- Length: EX-S (235-240 mm), S (235-240 mm), M (235-240 mm), L (235-240 mm)
- Width: EX S (70MM), S (82 mm), M (93 mm), L (107 mm)
- Thickness: EX S (0.10mm), S (0.10mm), M (0.10mm), L (0.10mm)
Physical Properties:
- Tensile Strength: Before Ageing (20-22 mpa), After Ageing (18-20 mpa)
- Elongation at break %: Before Ageing (750-850%), After Ageing (700-800%)
Inspection Level of AQL:
- Freedom from Holes: Holes, Level S4, AQL 1.5
- Dimension (Width, Length, Thickness): Level S2, AQL 4
- Physical Property (Tensile Strength, Elongation at Break): Level S2, AQL 4
Powder Content: 1 +/- 1 mg per glove
Protein Content: 80 +/- 20 ppm
Moisture Content: 0.8% max
Biocompatability: Biologically Compatible.
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.
Not Found
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
§ 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
510K SUMMARY as required by: 807.92( c ) 1.0.
2.0 APPLICANT
92(c)
K014279
MAR 2 0 2002
PAGE NO- 56
NAME
ADDRESS
M/s. BRIGHTWAY GLOVES PVT.LTD.
PIONEER MANIKANDAN BUILDINGS. VADASERY, NAGERCOIL, TAMIL NADU,
INDID-629001.
91-4652- 276291 / 276046 . PH.NO.
FAX NO 91-4652- 274271 .
CONTACT PERSON MR. N.PARAMASIVAN MANAGING DIRECTOR. 3. DEVICE TRADE NAME : NIL COMMON NAME : Latex Examination Glove (Powder free)
-
Legally marketed device to which the company claiming equivalence: Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578.
-
DESCRIPTION OF THE DEVICE:
Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578
- Intended use of the Device:
Latex Examination Glove (Powder free) is a Powder free devices made of Natural Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Image /page/0/Picture/15 description: The image shows 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 letters. There is a star symbol at the bottom of the stamp.
1
PAGE NO-57
7.0 TECHNOLOGICAL CHARACTERSTICS OF THE DEVICE COMAPARED TO PREDICATE DEVICE.
| Measured Parameters of Latex
Examination gloves (Powder free)
manufactured by Brightway Gloves
Pvt.Ltd., | | | ASTM D3578
Requirement for
Latex Examination
glove (Powder free) |
|-------------------------------------------------------------------------------------------------------------------|------|------------|---------------------------------------------------------------------------|
| 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 | Brightway | |||
| Gloves Value | ASTD 3578 | |||
| REQUIREMENT | Brightway | |||
| Gloves | ||||
| Value | ASTD 3578 | |||
| Requirement | ||||
| Tensile Strength | 20 - 22 mpa | 14 mpa min | 18 - 20 mpa | 14 mpa min |
| Elongation at break % | 750 - 800% | 700% min | 700-800% | 500% min |
Image /page/1/Picture/5 description: The image is a circular stamp with the words "BRIGHTWAY GLOVES PVT. LTD." written around the border of the circle. In the center of the circle, the word "NAGERCOIL" is written in bold letters. A five-pointed star is located at the bottom of the circle.
2
PAGE NO-58
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
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
Company of Children and College of College of Contract Concessfully children and Children Contraction of Children Contraction Concession Concession Concession Concession Conc
. | .
.
A
BREAD CONSULT OF COLLECTION COLLEGION COLLECTION COLLEGION COLLECTION COLLECTION COLLECTION COLLECTION COLLECTION COLLEGION COLLECTION COLLECTION COLLECTION COLLECTION COLLEC
.
A STATUTE A CONSULT OF
LEGILE II
and and the comments of the first of the first and the comments of the comments of the comments of the comments of the comments of the comments of the form of the former of t
CALLER BELL CREASE CONSULER COLLECTION CO
CONTRACT COLLEGICAL COLLEGION COLLEGE COLLEGIONAL |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ---------
.
LANSAN O
.
A Box 4 Total Concess and Career Schools and Childred | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 1984 1991-1991 1999 1999 1999 1999 1999 1999 1999 1999
- COR IN AND CONSULERS OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULTION OF CONSULT
Company of Children Company of Children Company of Children Company of Children
I a more in propos consistentialized by a |
PROTEIN CONTENT:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
The first and the program and the many of the county of the county of the county of the county of
Commender of the consisted on the can and the categories of the cated of the cated of
I makes and contraction with a many and
THE REAL PROPERTY LEAST LEAST LEAST STATUS COLLEGIAL
Fire from a montant of the contract of the contribution and the first and the | LEE REE E E RESER EN RESELLENTES
The Property of Children and Children and Children and Children Comments of Children
- 11. 11. 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
And Income of Children Commend Commend College of Children Comments of Children Comments of Children Comments of Children Comments of Children of Children of Children of Chil
A SHOR AND A
.
STATUTE FOR THE FORM FOR COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTIO
.
.
| A manager of the contracts of the first of the first for |
|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| --------- |
| 19 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 |
STATUTION CONSULTATION CONSULTATION CONSULTACALLARY
AND ANNUAL I ANNUALIZED AND LIGHT LE LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA LEA L
MAR R LE LEBERTE LE REGIONAL
14 11 11 11 10 10 10 100 10 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 10
Comments of Children College of Children
CONTRACT AND REALER COLOR COLUMN CALLERY
Carrely Station
1
. | Comment
. IN ALBURANT AND ANNALARIA ALL BULLER AND AND AND ALL PRODUCT AND
Caller Manager
Comments of the Comments of Children
The first and the county of the county of the county of the county of the county of |
MOISTURE CONTENT:
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
The first and the program and the state of the same of the same of the same of the same of
The The Research and Income and the commended of
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | "Hill Address and Children and the summer on the second of the second of the commended to the commended to the commended to the
I. IN NOW, CANNONIA FOR COLLEGE A COUNTY CANNOR PATIENT PATIENT PATIENT PATIENT PLANES OF CLAIM OF
Acres of the commended in
The program of the state of the state of the state of the state of the states of the states of
annual program and proposalism and the production of the continues and the continues and
and the comments of the consisted on the comments of the comments of the comments of the comments of
and and the state and problem
An and Change of Children Company of
and and the do station of the production of the de-
. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|
Canada
The first of the country of the county of the county of the county of the first of the first of the first and
Carles Comments of Concession Company Construction Comparison Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comp
COLLECTION WANTED CALL ALL ALL ALL ALL ALL ALL AND A BREATH AND A BREATH AND
Common an calculation of the pro-
STATUTE OF STATUTE AND THE LEASE OF LEASE OF CHEARTH
An anticle of the proposed
The summer of the control of the first of the first of the first of the first of the first and the first and the first and the first and the first and the first and the first
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 11 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1
To A LI MIND & MINNING A LE CONSULERS AND CONSULTION CON
Comprehensive program and proposition of the control control control control and concerner and concession of the control and concession of the contribution of the contributio |
BIOCOMPATABILITY: 1 :
| STATIS OF ARTS CHARACT LAND A FOR FOR
Barry of consideration of the different of the children
FREE EN FREE FREE FREE FOR FOR FOR FOR FOR
A B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L B L
CARD COLORIAL I CORRESS OF CHILIFERS
LAND AN AND COLLECTION COLLEGION COLLEGION
------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
IN AND LE FREEDERS COLLECTION
The first of the county of the county of the county of the county of the county of
· Children Children Children a provention a provention of a provention of a proventually of
140000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Callery of Children Controllers
.
.
| Comments of the comments of the program and the program and the comments of the comments of the comments of the comments of the comments of the first of the first of the firs |
|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 1 |
| Company College of the Cases of Children and Children and Charles and Charles for |
| LA MI LE LEAR REAL PRODUCTION COLLEGION COLLEGION COLLEGION COLLEGION CONTRACTOR COLLEGION CONTRACTOR COLLEGION OF |
| SHEET MILE A CHILLE WIER & LE BE LEWING |
Comments of the contraction of the comments of the comments of the first of the first of the first of
A MILL AND LEASE LEASE LEASE LEASE LEASE LEASE
Section of a consideration do a | CHARAC AND THE CONSULT CONSULTION CONSULTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION
Status of Children College
In more company and
STATUTE AND THE PERSONAL
Company of the control control control control control control control control of the consisted on the consisted on the consisted on the control of
ANNUAL PRODUCT OF CHARACT OF CHARACT OF CHARACT AND A CARDER A CARDER A CARRET A CARRETT A CARRET A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARAL A CARA A
.
STANDARD STATUTE LE LEASE MENT
.
The state of the count of the first and and and and and and the first and any and |
*BGPL-Brightway Gloves Pvt.ltd
Image /page/2/Picture/12 description: The image shows a circular stamp with the words "IGHTWAY GLOVES PVT. LTD" around the edge. In the center of the stamp, the word "HAGERCOIL" is written in a smaller font. The stamp appears to be slightly faded or worn, giving it a vintage or official look.
3
8.0 Performance Data:
The performance test data of the Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Lltd. is given below.
| Measured Parameters of Latex
Examination gloves (Powder free)
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
| CHARACTERISTICS | Before Ageing | After
Ageing |
|-----------------------|---------------|-----------------|
| Tensile Strength | 20-22 mpa | 18-20 mpa |
| Elongation at break % | 750-850% | 700-800% |
INSPECTION LEVEL OF 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 |
GLOVE 2 1 NAGERCALI
4
POWDER CONTENT: 1 +/- 1 mg per glove
PROTEIN CONTENT: 80 +/- 20 ppm
MOISTURE CONTENT: .0.8% max
BIOCO MPATABILITY: Biologically Compatible.
NA 9. Clinical Data 0
7. CONCLUSION OF PERFORMANCE TEST DATA:
The Latex Examination gloves Powder free manufactured by M/S Brightway Gloves Pvt.Ltd.
- Meet or exceed the ASTM D3578 a
- Meet FDA Pin hole Requirement. -
- Meet labelling claim as shown by the data in 6 -
8. ANY OTHER INFORMATION:
Any other information required by FDA regarding product safety and effectiveness will be provided on request.
Image /page/4/Picture/13 description: The image shows a circular stamp with the text "LIGHTWAY GLOVES PVT. LTD." around the outer edge of the circle. In the center of the circle, the text "NAGERCOIL" is printed in a bold, sans-serif font. The stamp appears to be slightly smudged, giving it a worn or used appearance.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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: K014279
Trade/Device Name: Latex Examination Gloves (Powder Free) 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
7
Page
510(k) NUMBER (IF KNOWN): K014279 LATEX EXAMINATION GLOVES (POWDER FREE) DEVICE NAME : INDICATIONS FOR USE:
EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.
(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)
OR
Over-The-Counter-Use (Optional Format 1-2-96
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number _