(111 days)
Not Found
No
The document describes a standard examination glove and does not mention any AI or ML components or functionalities.
No
The device is described as an examination glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a nitrile examination glove, which is used for protection during medical examinations, not for diagnosing conditions.
No
The device description clearly states it is a physical glove made from nitrile compound, which is a hardware component.
Based on the provided text, 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 that is worn on the examiner's hands or finger to prevent contamination patient and examiner". This describes a barrier device for physical protection, not a device used to examine specimens from the human body for diagnostic purposes.
- Device Description: The description focuses on the material (nitrile), color, powder-free nature, and sterility (non-sterile). It also mentions meeting standards for examination gloves and testing for chemotherapy drug permeation. None of these characteristics align with the definition of an IVD.
- Lack of IVD Indicators: The text does not mention any of the typical elements associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Reagents or assays
The device is a medical glove intended for barrier protection during medical examinations and procedures, including those involving chemotherapy drugs. This falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
Minimum Breakthrough Detection time in minutes, 0.01ug/cm2/minute Chemotherapy Drugs and Concentration
20.1 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
50.6 minutes
- 1)Carmustine (BCNU)(3.3mg/ml)
2)Cyclophosphamide (20mg/ml)
3)Cisplatin (1.0mg/ml)(1000ppm)
4)Doxorubicin Hydrochloride (2 mg/ml)
- Etoposide (20mg/ml)
- Fuorouracil (50mg/ml)
7)Methorexate (25mg/ml)
8)Paclitaxel (6mg/ml)
9)Thiotepa (10mg/ml)
The Maximum testing time is 240 minutes . Please note that the following drugs have low permeation time 1) Carmustine (BCNU)(3.3mg/ml) with Permeation time of 20.1 minutes 2) Thiotepa (10mg/ml) with Permeation time of 50.6 Minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / 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
The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Biocompatibility test / Modified Draize -95 test
Sample Size: 30 human subjects (stage 1) , minimum 205 individuals (stage 2)
Key Results: Biocompatibility test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant. The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested ariticle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Minimum Breakthrough Detection time in minutes, 0.01µg/cm²/minute for Chemotherapy Drugs:
Carmustine (BCNU) (3.3mg/ml): 20.1 minutes
Cyclophosphamide (20mg/ml): > 240 minutes
Cisplatin (1mg/ml): > 240 minutes
Doxorubicin Hydrochloride (2 mg/ml): > 240 minutes
Etoposide (20mg/ml): > 240 minutes
Fluorouracil (50mg/ml): > 240 minutes
Methorexate (25mg/ml): > 240 minutes
Paclitaxel (6mg/ml): > 240 minutes
Thiotepa (10mg/ml): 50.6 minutes
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.
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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2015
Riverstone Resources Sdn. Bhd. Mr. Suresh Kumar Quality Assurance Manager Lot 55 & 56, No 13, Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung Selangor 48300 MALAYSIA
Re: K152542
Trade/Device Name: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: Undated Received: November 30, 2015
Dear Mr. Kumar:
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.
1
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 and Part 809); medical device reporting of medical device-related 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 and Part 809), 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 yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152542
Device Name
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs
Indications for Use (Describe)
The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
Minimum Breakthrough Detection time in minutes, 0.01ug/cm2/minute Chemotherapy Drugs and Concentration
20.1 Minutes
240 Minutes > 240 Minutes
240 Minutes
240 Minutes
240 Minutes > 240 Minutes
240 Minutes
50.6 minutes
- 1)Carmustine (BCNU)(3.3mg/ml) 2)Cyclophosphamide (20mg/ml) 3)Cisplatin (1.0mg/ml)(1000ppm) 4)Doxorubicin Hydrochloride (2 mg/ml) 5) Etoposide (20mg/ml) 6) Fuorouracil (50mg/ml) 7)Methorexate (25mg/ml) 8)Paclitaxel (6mg/ml) 9)Thiotepa (10mg/ml)
The Maximum testing time is 240 minutes . Please note that the following drugs have low permeation time 1) Carmustine (BCNU)(3.3mg/ml) with Permeation time of 20.1 minutes 2) Thiotepa (10mg/ml) with Permeation time of 50.6 Minutes
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY -------
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
4
510(K) Summary Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs
1.0 Submitter :
| Company Name | : Riverstone Resources Sdn Bhd. |
|---|---|
| Company Address | : Lot 55 & 56,No 13, Jalan Jasmin 2 |
| Kawasan Perindustrian Bukit Beruntung | |
| 48300,Bukit Beruntung, | |
| Selangor,Malaysia. | |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| : qa1@riverstone.com.my |
2.0 Preparation Date : 14th December 2015
3.0 Name of the Device
Trade Name / Proprietary Name : Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy drugs.
Device Name : Nitrile Patient Examination gloves.
Device Classification Name : Patient Examination gloves (21 CFR 880.6250).
Device Class : Class I.
Product Code :LZA , LZC.
5
4.0) Identification of The Legally Marketed Device :
Class I patient Examination glove with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy Drugs, Powder Free, LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
Predicate Device: K050122. Powder Free Nitrile Examination (Blue) (This Product does not contain Thiuram and/or Carbamate and/or Thiazole) and K141623.EMG Blue Nitrile examination Gloves Powder Free with tested for use with Chemotherapy Drugs labeling claim
5.0 Device Description
The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
6.0 Intended use of the Device
A powder-free 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 .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.
6.0 Specification for Nitrile gloves: 6.1 Dimension and Thickness of Gloves
| Dimension | Size S | Size M | Size L | Size XL |
|---|---|---|---|---|
| Overall Length (mm) | 270min | 270min | 270min | 270min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
| Thickness at Finger Tip (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
6
6.1.2 Gloves Physical Properties and Holes
| Measurement | Before Ageing | After Aging at 70°C for
168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 |
Gloves meet all the specification listed in ASTM D 6319-10
| Characteristi
ભ્યું હિંદ્ર | Acceptance
Criteria | Powder Free
Nitrile Examination
Gloves(Blue) with
Low Dermatitis
Potential Claim and
with tested for use
with chemotherapy
drugs,K152542 | Powder Free
Nitrile
Examination
Gloves (This
Product does not
contain Thiuram
and/or Carbamate
and/or Thiazole)
,K050122 | EMG Blue Nitrile
Examination glove
Powder free with tested
for use with
Chemotherapy Drugs
labeling Claim,K141623 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA, LZC | LZA, LZC | LZA | LZA ,LZC |
| Intended use | A powder free
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.
The device is for
over-the-counter
use. | A powder free 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. The device
is for over-the-
counter use. | A powder free
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. The
device is for over-
the-counter use. | A powder free 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.
The device is for over-
the-counter use. |
| Material use | Nitrile | Nitrile | Nitrile | Nitrile |
| | compound | compound | compound | compound |
| Colour | Blue | Blue | Blue | Blue |
| Sterility
Single used | Non sterile | Non sterile | Non sterile
Single used | Non sterile
Single used |
| | Single used | Single used | | |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile | Non Sterile |
7
| Dimensions | Overall Length
(mm)
Min 270mm
Width (±5mm)
Size S =
85mm
Size M =
95mm
Size L =
105mm
Size XL =
115mm
Thickness at Palm
(mm)
Min; 0.10 mm
Thickness at
Finger Tip (mm)
Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Appendix 2
Meets ASTM D6319-10 | Biological Evaluation on Medical Device --Primary Skin Irritation Test | | | Appendix 2 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | Biological Evaluation on Medical Device -Primary Skin Irritation Test | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | | | | |
| Physical properties | Before Ageing
Tensile Strength
(MPa)
= 14min
Ultimate
Elongation (%)
= 500min
After Aging at
70°C for
168 hrs @ 100°C
for 22 hrs
Tensile Strength
(MPa)
= 14min
Ultimate
Elongation (%)
= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Biological Evaluation on Medical Device -Dermal Sensitization Assay | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| | Resistance against Chemotherapy Drugs | 1) Carmustine (3.3mg/ml or 3000ppm), Breakthrough : 20.1 min.
2) Cyclophosphamide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.
3) Cisplatin (1mg/ml or 1000ppm), Breakthrough time : > 240 min
4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Breakthrough time : >240 min.
5) Etoposide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.
6) Flourouracil (50mg/ml or 50,000), Breakthrough time : >240 min.
7) Methotrexate (25mg/ml or 25,000ppm), Breakthrough time : > 240 min | | 1) Carmustine (3.3mg/ml or 3000ppm), Breakthrough: 4.5min.
2) Cyclophosphamide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.
3) Cytarabine (100mg/ml or 100,000ppm), Breakthrough time : >240 min
4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Breakthrough time : >240 min.
5) Etoposide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.
6) Flourouracil (50mg/ml or 50,000), Breakthrough time: >240 min.
7) Methotrexate (25mg/ml or 25,000ppm), Breakthrough time : > 240 min. | | | | |
| Freedom from
pinholes | AQL 2.5
Inspection Level
G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | | | | |
| Residual Powder | 240 min. | 8) Paclitaxel (6mg/ml or
6,000ppm), Breakthrough
time : >240 min. |
| | | 9) Thiotepa (10mg/ml
or 10,000ppm),
Breakthrough time :
50.6 min. | 9) Thiotepa (10mg/ml or
10,000ppm),
Breakthrough time : 6.88
min. |
| Low Dermatitis
Potential Claim | 1)Modified
Draize 95 test | No Clinical evidence
presence of residual
chemical additives
that may induce Type
IV allergy in human
subject | No Clinical
evidence presence
of residual
chemical additives
that may induce
Type IV allergy in
human subject |
Resistance against Chemotherapy Drugs
| Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes,0.01µg/cm²/minute |
|---|---|
| 1)Carmustine (BCNU) (3.3mg/ml) | 20.1 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cisplatin (1mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 50.6 minutes |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)
10
7.0) Substantial Equivalent 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 test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant
8.0) Substantial Equivalent Based on Assessment of Clinical Performance Data
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".
The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability
The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested ariticle.
11
9.0 Conclusion
Based on intended uses, technological characteristics and Non-Clinical performance data, Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for Use with Chemotherapy drugs is substantially equivalent to the predicate device (K050122) and (K141623)