(107 days)
Not Found
No
The 510(k) summary describes a standard surgical glove and its performance testing against established standards, with no mention of AI or ML capabilities.
No
This device is a surgical glove intended for protection against contamination and chemicals, not for treating a disease or condition.
No
This device is a surgical glove intended to protect surgical wounds from contamination and operating room personnel from chemotherapy drugs. Its purpose is protective, not diagnostic.
No
The device description clearly states it is a "Sterile Polyisoprene Powder Free Surgical Glove," which is a physical hardware product. The performance studies and key metrics also relate to the physical properties and performance of a glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and for use with chemotherapy drugs. This is a barrier function and a protective function, not a diagnostic function performed in vitro (outside the body).
- Device Description: It's a surgical glove, a physical barrier.
- Lack of Diagnostic Function: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
- Testing: The testing performed relates to the physical properties of the glove, its barrier function, and its resistance to chemicals, not to diagnostic performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical glove does not fit that definition.
N/A
Intended Use / Indications for Use
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05(Reapproved 2019).
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |
| Vincristine Sulfate (1mg/ml) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes Warning: Do not use with Carmustine and Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
KGO, LZC
Device Description
Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
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)
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.
- ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2022) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-5 In Vitro Cytotoxicity
- ISO 10993-23 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogen Test
- U.S. Pharmacopeia Sterility Test
- U.S. Pharmacopeia endotoxin test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: Minimum 265mm, Result 280-305mm (Pass)
- Palm Width (size):
- 5.5: 70+/-6 (mm), Result 73 (Pass)
- 6.0: 76+/-6 (mm), Result 79 (Pass)
- 6.5: 83+/-6 (mm), Result 84 (Pass)
- 7.0: 89+/-6 (mm), Result 90 (Pass)
- 7.5: 95+/-6 (mm), Result 96 (Pass)
- 8.0: 102+/-6 (mm), Result 101 (Pass)
- 8.5: 108+/-6 (mm), Result 108 (Pass)
- 9.0: 114+/-6 (mm), Result 114 (Pass)
- Thickness:
- Finger: Minimum 0.10, Result 0.22-0.24 (Pass)
- Palm: Minimum 0.10, Result 0.22 (Pass)
- Cuff: Minimum 0.10, Result 0.17-0.18 (Pass)
- Tensile Strength, Before Aging: 17MPa, min, Average 20-21MPa (Pass)
- Ultimate Elongation, Before Aging: 650%, min, Average 780-823% (Pass)
- Stress at 500% Elongation: 7.0 MPa, max, Average 2.5-3.1MPa (Pass)
- Tensile Strength, After Accelerated Aging: 12 MPa, min, Average 18-20MPa (Pass)
- Ultimate Elongation, After Accelerated Aging: 490%, min, Average 747-809 % (Pass)
- Freedom from holes: Meets AQL1.5 (Pass)
- Residual Powder:
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 13, 2023
Grand Work Plastic Products Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino, California 91710
Re: K230217
Trade/Device Name: Sterile Polyisoprene Powder Free Surgical Glove, 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: April 11, 2023 Received: April 12, 2023
Dear Kathy Liu:
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 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); 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 mediation-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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. 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
2
Indications for Use
510(k) Number (if known) K230217
Device Name
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05(Reapproved 2019).
| Chemotherapy Drug | Minimum Breakthrough Detection Time (BDT) in Minutes |
|---|---|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |
| Vincristine Sulfate (1mg/ml) | >240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes 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)
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3
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.
The assigned 510(K) number is: K230217 Date Prepared: March 25, 2023
1. Owner's Identification:
Mrs. Wu Yuli Grand Work Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, 050000, China Tel: 86-311-66179668
Contact: Ms. Kathy Liu, Project Manager Grand Work Plastic Products Co., Ltd Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611
2. Name of the Device:
Trade Name: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs Common Name: Surgeon's Glove Classification Name: Surgeon's Glove Classification Regulation: 21 CFR 878.4460 Product Code: KGO, LZC Device Class: Class I
3. Predicate Device Information:
Hartalega NGC SDN BHD Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) (K221718)
4. Device Description:
Sterile Polyisoprene Powder Free Surgical Glove, tested for Use with Chemotherapy Drugs is a disposable singleuse, sterile, Cream-colored and powder-free surgical glove made from synthetic polyisoprene latex.
5. Indications for Use:
This glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2019).
| Chemotherapy Drug | Minimum BDT (Minutes) |
|---|---|
| Carmustine (3.3mg/ml) | 25.4 |
| Cisplatin (1mg/ml) | >240 |
| Cyclophosphamide (20mg/ml) | >240 |
| Doxorubicin HCL (2 mg/ml) | >240 |
| Etoposide (20mg/ml) | >240 |
| Fluorouracil (50mg/ml) | >240 |
| Methotrexate (25mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6mg/ml) | >240 |
| Thiotepa (10mg/ml) | 23.3 |
4
Vincristine Sulfate (1 mg/ml)
240
Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes Warning: Do not use with Carmustine and Thiotepa
6. Comparison table of Subject Device and Predicate Device:
| Items | Subject Device
K230217 | Predicate Device
K221718 | Remark |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | Sterile Polyisoprene Powder
Free Surgical Glove, Tested for
Use with Chemotherapy Drugs | Polyisoprene Powder Free Surgical Glove
Tested for Use with Chemotherapy Drugs
(Natural) | Similar |
| Product Code | KGO, LZC | KGO, LZC | Same |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Classification | I | I | Same |
| Regulation Name | Surgeon's Glove | Surgeon's Glove | Same |
| Indications for Use | This glove is intended to be
worn by operating room
personnel to protect a surgical
wound from contamination. In
addition, these gloves were
tested for use with
chemotherapy drugs in
accordance with ASTM
D6978-05 (Reapproved 2019). | Polyisoprene Powder Free Surgical Glove
Tested for Use with Chemotherapy Drugs
is intended to be worn by operating room
personnel to protect surgical wound from
contamination. It is also tested for use
against Chemotherapy Drugs.
The gloves were tested for use with
chemotherapy drugs as per ASTM D6978-
05 (Reapproved 2019) Standard Practice
for Assessment of Resistance of Medical
Gloves to Permeation by Chemotherapy
Drugs. | Similar |
| Type of use | Over the counter use | Over the counter use | Same |
| Materials | Polyisoprene | Polyisoprene | Same |
| Color | Cream | Natural | Different |
| Design | · Single Use
· Sterile
• Powder-Free
· Hand Specific
• Beaded cuff | · Single Use
· Sterile
• Powder-Free
· Hand Specific
• Beaded cuff | Same |
| Sterility | Sterile | Sterile | Same |
| Sterilization | Radiation 10-6 SAL | Radiation 10-6 SAL | Same |
| Freedom from
holes | Meets ASTM D3577-19
requirements of AQL 1.5 | Meets ASTM D3577-19 requirements of
AQL 1.5 | Similar |
| Length | Length (mm): ≥ 265 mm | Length (mm): ≥ 265 mm | Similar |
| Dimensions | 5.5:70 ± 6 (mm)
6.0: 76 ± 6 (mm)
6.5: 83 ± 6 (mm)
7.0: 89 ± 6 (mm)
7.5: 95 ± 6 (mm)
8.0: 102 ± 6 (mm)
8.5: 108 ± 6 (mm)
9.0: 114 ± 6 (mm) | 5.5:70 ± 6 (mm)
6.0: 76 ± 6 (mm)
6.5: 83 ± 6 (mm)
7.0: 89 ± 6 (mm)
7.5: 95 ± 6 (mm)
8.0: 102 ± 6 (mm)
8.5: 108 ± 6 (mm)
9.0: 114 ± 6 (mm) | Similar |
| Thickness | Cuff Thickness: ≥ 0.10 mm
Palm Thickness: ≥ 0.10 mm | Cuff Thickness: ≥ 0.10 mm
Palm Thickness: ≥ 0.10 mm | Similar |
| | Finger Thickness: ≥ 0.10 mm | Finger Thickness: ≥ 0.10 mm | |
| Physical
Properties | Tensile Strength Before Aging:
≥ 17 MPa
Tensile Strength After Aging: ≥
12 MPa
Ultimate Elongation Before
Aging: ≥ 650 %
Ultimate Elongation After
Aging: ≥ 490 % | Tensile Strength Before Aging: ≥ 17 MPa
Tensile Strength After Aging: ≥ 12 MPa
Ultimate Elongation Before Aging: ≥
650 %
Ultimate Elongation After Aging: ≥ 490 % | Similar |
| Powder residual | Residual Powder: ≤ 2 mg per
glove | Residual Powder: ≤ 2 mg per glove | Similar |
| In Vitro Cytotoxicity | Under the conditions of this
study, the test article extract
showed potential toxicity to
L929 cells. | Under the conditions of the study, the
device was found to be cytotoxic | Similar |
| Primary Skin
Irritation | The test result showed that the
polar and non-polar extract of
the final test sample score is less
1.0, the requirements of the test
are met. | Under the conditions of the study, the
device is not an irritant | Similar |
| Dermal Sensitization | Under the conditions of this
study, the test article extract
showed no significant evidence
of causing skin sensitization | Under the conditions of the study, the
device is not a sensitizer | Similar |
| Acute Systemic
Toxicity | Under the conditions of this
study, there was no evidence
of Acute systemic toxicity
from the extract.
The test article extract met the
requirements of this study. | Under the conditions of the study, there
was no evidence of systemic toxicity | Similar |
| Pyrogenicity Test | Under the conditions of this
study, no rabbit shows an
individual rise in temperature of
0.5℃ or more, the test article
Sterile Polyisoprene Powder
Free Surgical Gloves, Tested for
Use with Chemotherapy Drugs
meets the requirements of
pyrogen test. | Under the conditions of the study, the test
article was non-pyrogenic | Similar |
| Endotoxin Test | ≤0.5 units/pair of gloves | Not Performed | Different |
| Chemotherapy Drug
Permeation Claim | See below comparison table | See below comparison table | Similar |
5
Chemotherapy Permeation Comparison Claim:
| Tested Chemotherapy Drug and | Minimum BDT (Minutes) | Remark | |
|---|---|---|---|
| Concentration | Subject Device | ||
| K230217 | Predicate Device | ||
| K221718 | |||
| Carmustine (3.3mg/ml) | 25.4 | 12.3 | Similar |
| Cisplatin (1mg/ml) | >240 | >240 | Same |
| Cyclophosphamide (20mg/ml) | >240 | >240 | Same |
6
| Dacarbazine (10.0 mg/ml) | Not performed | >240 | Different* |
|---|---|---|---|
| Doxorubicin HCL (2 mg/ml) | >240 | >240 | Same |
| Etoposide (20mg/ml) | >240 | >240 | Same |
| Fluorouracil (50mg/ml) | >240 | >240 | Same |
| Methotrexate (25mg/ml) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/ml) | >240 | >240 | Same |
| Paclitaxel (6mg/ml) | >240 | >240 | Same |
| Thiotepa (10mg/ml) | 23.3 | 17.4 | Similar |
| Vincristine Sulfate (1 mg/ml) | >240 | >240 | Same |
- Chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this difference does not raise questions of safetv and effectiveness.
7 Summary of Non-Clinical Testing
Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications. The test results demonstrated that the subject device complies with the following standards as shown below.
- · ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
- · ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- · ASTM D6124-06 (Reapproved 2022) Standard Test Method for Residual Powder on Medical Gloves
- · ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to
- Permeation by Chemotherapy Drugs
- ISO 10993-5 In Vitro Cytotoxicity
- ISO 10993-23 Primary Skin Irritation
- ISO 10993-10 Dermal Sensitization
- · ISO 10993-11 Acute Systemic Toxicity
- ISO 10993-11 Pyrogen Test
- · U.S. Pharmacopeia Sterility Test
- · U.S. Pharmacopeia endotoxin test
8. Specification for subject Gloves:
| Technological
| Characteristics | Standard/Test/FDA Guidance | Result Summary | Conclusion |
|---|---|---|---|
| Dimensions | ASTM D3577-19 | Meets ASTM D3577 | |
| requirements for length, width | |||
| and thickness | Same | ||
| --Length | Minimum 265mm | 280-305mm | Pass |
| --Palm Width (size) | (mm) | Average value in mm | |
| 5.5 | 70±6 | 73 | Pass |
| 6.0 | 76±6 | 79 | Pass |
| 6.5 | 83±6 | 84 | Pass |
| 7.0 | 89±6 | 90 | Pass |
| 7.5 | 95±6 | 96 | Pass |
| 8.0 | 102±6 | 101 | Pass |
| 8.5 | 108±6 | 108 | Pass |
| 9.0 | 114±6 | 114 | Pass |
| --Thickness | Average value in mm | ||
| Finger | Minimum 0.10 | 0.22-0.24 | Pass |
| Palm | Minimum 0.10 | 0.22 | Pass |
| Cuff | Minimum 0.10 | 0.17-0.18 | Pass |
| Physical Properties | ASTM D3577-19 | Meets ASTM D3577-19 | |
| Tensile Strength, Before | 17MPa, min | Average 20-21MPa | Pass |
7
| Aging | |||
|---|---|---|---|
| Ultimate Elongation, | |||
| Before Aging | 650%, min | Average 780-823% | Pass |
| Stress at 500% Elongation | 7.0 MPa, max | Average 2.5-3.1MPa | Pass |
| Tensile Strength, After | |||
| Accelerated Aging | 12 MPa, min | Average 18-20MPa | Pass |
| Ultimate Elongation, After | |||
| Accelerated Aging | 490%, min | Average 747-809 % | Pass |
| Freedom from holes | ASTM D3577-19 | ||
| ASTM D 5151-19 | |||
| requirements of AQL1.5 | Meets AQL1.5 | Pass | |
| Powder-Free | ASTM D3577-19 | ||
| ASTM D 6124-06(2022) | |||
| $\leq$ 2 mg per glove | 0.10-0.27 mg per glove | Pass | |
| Aqueous Extractable | |||
| Protein Content | ASTM D3577-19 | ||
| ASTM D5712-15 | |||
| $\leq$ 200ug/dm2 | $\leq$ =50ug/dm2 | Pass | |
| Sterility | 10-6 SAL | 10-6 SAL | Pass |
9. Biocompatibility
| Test | Result Summary |
|---|---|
| Skin Sensitization Test | |
| ISO 10993-10 | Under the conditions of this study, the test article extract showed no significant |
| evidence of causing skin sensitization | |
| Intracutaneous Reactivity Test | |
| ISO 10993-23 | The test result showed that the polar and non-polar extract of the final test |
| sample score is less 1.0, the requirements of the test are met. | |
| Cytotoxicity Test | |
| ISO 10993-5 | Under the conditions of this study, the test article extract showed potential |
| toxicity to L929 cells. | |
| Acute Systemic Toxicity Test | |
| 10993-11 | Under the conditions of this study, there was no evidence of Acute systemic |
| toxicity from the extract. | |
| The test article extract met the requirements of this study. | |
| Pyrogen Test | |
| 10993-11 | Under the conditions of this study, no rabbit shows an individual rise in |
| temperature of 0.5°C or more, the test article Sterile Polyisoprene Powder Free | |
| Surgical Gloves, Tested for Use with Chemotherapy Drugs meets the | |
| requirements of pyrogen test. |
10. Clinical Performance Data:
Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device.
11. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the Subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.