ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Device Facts
| Record ID | K210724 |
|---|---|
| Device Name | ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs |
| Applicant | Careplus (M) Sdn Bhd |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | Aug 3, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Story
Sterile, powder-free latex surgical gloves; surface-treated on exterior; polymer-coated on interior. Used by operating room personnel to protect surgical wounds from contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978. Provides barrier protection during surgical procedures. Not for use with Carmustine or Thiotepa.
Clinical Evidence
No clinical data. Bench testing only, including ASTM D3577 (physical properties, dimensions, powder content), ASTM D5151 (freedom from holes), ASTM D6978 (chemotherapy drug permeation), ASTM D5712 (protein content), and ISO 10993 (biocompatibility).
Technological Characteristics
Material: Latex with titanium dioxide pigment. Form: Powder-free, polymer-coated interior, surface-treated exterior. Sterilization: Gamma irradiation. Standards: ASTM D3577, ASTM D5151, ASTM D6124, ASTM D6978, ISO 10993. Shelf-life: 3 years.
Indications for Use
Indicated for operating room personnel to protect surgical wounds from contamination. Sterile, disposable, powder-free latex surgical gloves.
Regulatory Classification
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.
Predicate Devices
- Encore Acclaim Sterile Powder Free Latex Surgical Gloves (K103714)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2021
Careplus (M) SDN BHD Lim Shyan CEO/ Managing Director Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, Negeri Sembilan 70450 Malaysia
Re: K210724
Trade/Device Name: ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: June 22, 2021 Received: June 28, 2021
Dear Lim Shyan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Clarence W. Murray III -S
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
# 510(k) Number (if known) K210724
## Device Name
ENCORE® Latex Acclaim, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (< 50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Indications for Use (Describe)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minute |
|----------------------------------------|-----------------------------------------------|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 14.1 |
| Thiotepa (10.0mg/ml) | 16.9 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >240 |
"WARNING: Do not use with Carmustine and Thiotepa"
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response. including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
# 510(k) Number (if known) K210724
### Device Name
GAMMEX® Latex Standard, Powder free Latex Surgical Gloves with Protein Labeling Claim (< 50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
# Indications for Use (Describe)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minutes |
|----------------------------------------|------------------------------------------------|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 14.1 |
| Thiotepa (10.0mg/ml) | 16.9 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >240 |
"WARNING: Do not use with Carmustine and Thiotepa"
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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# K210724
# 510(K) SUMMARY
- 1.0 Applicant: CAREPLUS (M) SDN BHD
- Lot 120 & 121 , Jalan Senawang 3, Address: Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. 60-6-6772781 Fax No. 60-6-6772780
Contact Person Lim Kwee Shyan
- 2.0 Date of Summary 31st July, 2021
# 3.0 Device Information
Device Name: Surgeons Glove, Latex Powder Free with Protein Content Labeling Claim (< 50 µg/dm² per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Glove Trade Name: ENCORE® Latex Acclaim, Powder free Latex Surgical Gloves with Protein Content Labeling Claim (< 50 µg/dm² per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
> GAMMEX® Latex Standard. Powder free Latex Surgical Gloves with Protein Content Labeling Claim (< 50 uq/dm² per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Common Name: Surgical Gloves Product Code: KGO Subsequent Product Code: LZC Classification Name: Surgeon's Gloves Patient Examination Gloves Specialty (21 CFR 880.6250, KGO)
# 4.0 Device Description
It is the powder-free variation of the class I sterile latex surgical gloves made on-line by surface treatment on the outside and polymer coating on inner surface.
# 5.0 Predicate Device
Predicate device: Encore Acclaim Sterile Powder Free Latex Surgical Gloves, Tested for use with Chemotherapy Drugs with a Protein Content Label Claim <50 ug/dm2 per Glove of Extractable Protein, 510(k) number K103714, product code KGO.
# 6.0 Intended Use of Device
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
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# K210724
| 7.0 Technological Characteristics Comparison | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics | Subject Glove<br>(ENCORE® Latex Acclaim, Powder free<br>Latex Surgical Gloves with Protein<br>Content Labeling Claim (< 50 μg/dm²<br>per glove of total aqueous extractable<br>protein) and Tested for use with<br>Chemotherapy drugs<br>,K210724) | Predicate Device<br>(Encore Acclaim Sterile Powder Free<br>Latex Surgical Gloves, Tested for use<br>with Chemotherapy Drugs with a<br>Protein Content Label Claim, K103714) | Discussion |
| Product Code | KGO<br>LZC | KGO<br>LZC | Same |
| Regulation Number | 21CFR878.4460<br>21CFR880.6250 | 21CFR878.4460<br>21CFR880.6250 | Same |
| Device Class | Class 1 | Class 1 | Same |
| Freedom from holes | Meets ASTM D3577<br>Meets ASTM D5151 | Meets ASTM D3577<br>Meets ASTM D5151 | Same |
| Dimension | | | Same |
| Length (size: 5.5), mm<br>Length (size: 6.0), mm<br>Length (size: 6.5), mm<br>Length (size: 7.0), mm<br>Length (size: 7.5), mm<br>Length (size: 8.0), mm<br>Length (size: 8.5), mm<br>Length (size: 9.0), mm<br>Thickness (cuff), mm<br>Thickness (palm), mm<br>Thickness (finger), mm<br>Width (size: 5.5), mm<br>Width (size: 6.0), mm<br>Width (size: 6.5), mm<br>Width (size: 7.0), mm<br>Width (size: 7.5), mm<br>Width (size: 8.0), mm<br>Width (size: 8.5), mm<br>Width (size: 9.0), mm | Meet 245mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 0.10mm min<br>Meet 0.10mm min<br>Meet 0.10mm min<br>Meet 70 ± 6 mm<br>Meet 76 ± 6 mm<br>Meet 83 ± 6 mm<br>Meet 89 ± 6 mm<br>Meet 95 ± 6 mm<br>Meet 102 ± 6 mm<br>Meet 108 ± 6 mm<br>Meet 114 ± 6 mm | Meet 245mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 265mm min<br>Meet 0.10mm min<br>Meet 0.10mm min<br>Meet 0.10mm min<br>Meet 70 ± 6 mm<br>Meet 76 ± 6 mm<br>Meet 83 ± 6 mm<br>Meet 89 ± 6 mm<br>Meet 95 ± 6 mm<br>Meet 102 ± 6 mm<br>Meet 108 ± 6 mm<br>Meet 114 ± 6 mm | |
| Physical Properties<br>(Before Ageing)<br>i) Tensile Strength(Mpa)<br>ii) Ultimate Elongation(%)<br>iii) Stress at 500%<br>Elongation<br>(After Ageing)<br>i) Tensile Strength(Mpa)<br>ii) Ultimate Elongation(%) | Meets ASTM D3577 | Meets ASTM D3577 | Same |
| Powder Content | Meets ASTM D3577<br>Meets ASTM D6124 | Meets ASTM D3577<br>Meets ASTM D6124 | Same |
| Biocompatibility Test<br>i) Primary Skin Irritation<br>Test<br>ii) Dermal Sensitization<br>Test | Passes<br>i) Primary Skin Irritation Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not cause<br>and irritant response.<br>ii) Dermal Sensitization Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not produce<br>a skin sensitization effect. | Passes<br>i) Primary Skin Irritation Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not cause<br>and irritant response.<br>ii) Dermal Sensitization Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not produce<br>a skin sensitization effect. | Same |
| iii) In Vitro Cytotoxicity Test | iii) In vitro Cytotoxicity test.<br>Conclusions: Under the conditions of<br>this study, the test material is Cytotoxic<br>at dilutions of 1:2, 1:4, 1:8, 1:6 and<br>Non-cytotoxic, grade 2 at 1:32 and 1:64<br>dilutions. | iii) No data available | Different |
| iv) Acute Systemic Toxicity | iv) Acute Systemic Toxicity study.<br>Conclusion: Under the conditions of this<br>study, the test material both inner and<br>outer surface did not reveal systemic<br>toxicity. | iv) No data available | Different |
| Protein Label Claim | Contains 50 µg/dm² or less per glove of<br>total aqueous extractable protein of<br>total water extractable protein per gram. | Contains 50 micrograms or less of total<br>aqueous extractable protein of total<br>water extractable protein per gram. | Same |
| Chemo Drugs Claim | Chemo Claim | Chemo Claim | Same |
| Color | Natural | Natural | Same |
| White Pigment | Titanium Dioxide | Titanium Dioxide | Same |
| Indications for use | Powder Free Surgical gloves are sterile<br>disposable devices intended to be worn<br>by operating room personnel to protect<br>a surgical wound from contamination. | Powder Free Surgical gloves are sterile<br>disposable devices intended to be worn<br>by operating room personnel to protect<br>a surgical wound from contamination. | Same |
| Shelf-life | 3 years | 3 years | Same |
| Sterile Packaging | Packed 1 pair in a wallet. One wallet in<br>a pouch. | Packed 1 pair in a wallet. One wallet in<br>a pouch. | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same |
| Characteristics | Subject Glove | Predicate Device | Discussion |
| | (GAMMEX® Latex Standard, Powder<br>free Latex Surgical Gloves with Protein<br>Content Labeling Claim (< 50 µg/dm²<br>per glove of total aqueous extractable<br>protein) and Tested for use with<br>Chemotherapy drugs<br>,K210724) | (Encore Acclaim Sterile Powder Free<br>Latex Surgical Gloves, Tested for use<br>with Chemotherapy Drugs with a<br>Protein Content Label Claim, K103714) | |
| Product Code | KGO<br>LZC | KGO<br>LZC | Same |
| Regulation Number | 21CFR878.4460<br>21CFR880.6250 | 21CFR878.4460<br>21CFR880.6250 | Same |
| Device Class | Class 1 | Class 1 | Same |
| Freedom from holes | Meets ASTM D3577<br>Meets ASTM D5151 | Meets ASTM D3577<br>Meets ASTM D5151 | Same |
| Dimension | | | Same |
| Length (size: 5.5), mm | Meet 245mm min | Meet 245mm min | |
| Length (size: 6.0), mm | Meet 265mm min | Meet 265mm min | |
| Length (size: 6.5), mm | Meet 265mm min | Meet 265mm min | |
| Length (size: 7.0), mm | Meet 265mm min | Meet 265mm min | |
| Length (size: 7.5), mm | Meet 265mm min | Meet 265mm min | |
| Length (size: 8.0), mm | Meet 265mm min | Meet 265mm min | |
| Length (size: 8.5), mm | Meet 265mm min | Meet 265mm min | |
| Length (size: 9.0), mm | Meet 265mm min | Meet 265mm min | |
| Thickness (cuff), mm | Meet 0.10mm min | Meet 0.10mm min | |
| Thickness (palm), mm | Meet 0.10mm min | Meet 0.10mm min | |
| Thickness (finger), mm | Meet 0.10mm min | Meet 0.10mm min | |
| Width (size: 5.5), mm | Meet 70 ± 6 mm | Meet 70 ± 6 mm | |
| Width (size: 6.0), mm | Meet 76 ± 6 mm | Meet 76 ± 6 mm | |
| Width (size: 6.5), mm | Meet 83 ± 6 mm | Meet 83 ± 6 mm | |
| Width (size: 7.0), mm | Meet 89 ± 6 mm | Meet 89 ± 6 mm | |
| Width (size: 7.5), mm | Meet 95 ± 6 mm | Meet 95 ± 6 mm | |
| Width (size: 8.0), mm | Meet 102 ± 6 mm | Meet 102 ± 6 mm | |
| Width (size: 8.5), mm | Meet 108 ± 6 mm | Meet 108 ± 6 mm | |
| Width (size: 9.0), mm | Meet 114 ± 6 mm | Meet 114 ± 6 mm | |
| Physical Properties<br>(Before Ageing)<br>i) Tensile Strength(Mpa)<br>ii) Ultimate Elongation(%)<br>iii) Stress at 500%<br>Elongation | Meets ASTM D3577 | Meets ASTM D3577 | Same |
| (After Ageing)<br>i) Tensile Strength(Mpa)<br>ii) Ultimate Elongation(%) | Meets ASTM D3577 | Meets ASTM D3577 | Same |
| Powder Content | Meets ASTM D3577<br>Meets ASTM D6124 | Meets ASTM D3577<br>Meets ASTM D6124 | Same |
| Biocompatibility Test<br>i) Primary Skin Irritation<br>Test | Passes<br>i) Primary Skin Irritation Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not cause<br>and irritant response. | Passes<br>i) Primary Skin Irritation Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not cause<br>and irritant response. | Same |
| ii) Dermal Sensitization<br>Test | ii) Dermal Sensitization Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not produce<br>a skin sensitization effect. | ii) Dermal Sensitization Test.<br>Conclusion: Under the conditions of this<br>study, the test material did not produce<br>a skin sensitization effect. | Same |
| iii) In Vitro Cytotoxicity Test | iii) In vitro Cytotoxicity test.<br>Conclusions: Under the conditions of<br>this study, the test material is Cytotoxic<br>at dilutions of 1:2, 1:4, 1:8, 1:6 and<br>Non-cytotoxic, grade 2 at 1:32 and 1:64<br>dilutions. | iii) No data available | Different |
| iv) Acute Systemic Toxicity | iv) Acute Systemic Toxicity study.<br>Conclusion: Under the conditions of this<br>study, the test material both inner and<br>outer surface did not reveal systemic<br>toxicity. | iv) No data available | Different |
| Protein Label Claim…
