(134 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.
| Characteristic | Acceptance Criteria (Standard) | Blue Glove Performance (Reported) | Cobalt Blue Glove Performance (Reported) |
|---|---|---|---|
| Chemotherapy Permeation (ASTM D6978-05) | (Comparison to predicate and general clinical expectation of protection) | See detailed table below | See detailed table below |
| Carboplatin, 10mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Carmustine, 3.3mg/ml | No specific numerical acceptance listed | 15.0 minutes | 2.4 minutes |
| Cisplatin, 1.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Cyclophosphamide, 20.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Dacarbazine, 10.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Doxorubicin HCl, 2.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Etoposide, 20.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Fluorouracil, 50.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Ifosfamide, 50.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Methotrexate, 25mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Mitomycin C, 0.5mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Mitoxantrone, 2mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Paclitaxel, 6.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| ThioTEPA, 10.0mg/ml | No specific numerical acceptance listed | 30.1 minutes | 1.9 minutes |
| Vincristine Sulfate, 1.0mg/ml | No specific numerical acceptance listed, but >240 min is ideal | > 240 minutes | > 240 minutes |
| Physical (ASTM D6319-10) | Meets ASTM D6319-10 specifications | Meets | Meets |
| Dimension (Length) | Min 240mm (ASTM D6319-10) | Min 240mm | Min 240mm |
| Thickness (Finger) | No specific numerical acceptance for subject devices listed, predicate 0.03-0.05mm | 0.03mm min | 0.03mm min |
| Thickness (Palm) | No specific numerical acceptance for subject devices listed, predicate 1.5-0.08mm | 0.05mm min | 0.05mm min |
| Thickness (Cuff) | No specific numerical acceptance for subject devices listed, predicate 1.6-0.09mm | 0.05mm min | 0.05mm min |
| Powder-free | <2mg/glove (ASTM D6124-06) | Meets | Meets |
| Water tightness (1000ml) | Passes (Predicate performance) | Passes | Passes |
| Biocompatibility (ISO 10993-10) | Not a primary skin irritant / Not a contact sensitizer | Device is non-irritant / non-sensitizer | Device is non-irritant / non-sensitizer |
Warning Statements related to acceptance/use:
- Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."
- Cobalt Blue Glove: "WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 2.4 minutes and ThioTepa: 1.9 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA."
Study Proving Device Meets Acceptance Criteria:
The device's performance is demonstrated through testing against recognized standards. The document is a 510(k) summary for premarket notification, which means the manufacturer conducted tests to show substantial equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, water tightness, or biocompatibility). The testing is generally indicated as "Meets" specific ASTM/ISO standards, which typically prescribe minimum sample sizes for conformity testing.
- Data Provenance: The tests were conducted to support a premarket notification for devices manufactured by YTY Industry (Manjung) Sdn Bhd in Malaysia. This suggests the data originates from tests conducted by or for the manufacturer, likely in an accredited lab to demonstrate compliance with the referenced international standards. The data is retrospective in the context of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate device characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for glove performance testing (e.g., permeation time, physical properties) is established through standardized laboratory methods and instrument readings, not expert consensus or interpretation of images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as the determination of device characteristics (e.g., breakthrough time, physical dimensions) is based on objective measurements and standardized test protocols, not on human expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This document describes performance testing for medical gloves, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance claims of these gloves is based on:
- Standardized Test Methods: Adherence to established international standards like ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, and ISO 10993-10.
- Objective Measurements: Laboratory measurements of physical properties (e.g., dimensions, thickness, water leakage, powder content) and chemical permeation breakthrough times using specified equipment and protocols.
8. The sample size for the training set:
This is not applicable. The device is a manufactured good (gloves), not an AI model requiring a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
{0}------------------------------------------------
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Yty Industry (manjung) Sdn Bhd Punitha Samy Deputy Manager-DC/RA Lot 1422-1424, Batu 10 Lekir Sitiawan, 32020 My
Re: K171104
Trade/Device Name: Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue) and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: July 19, 2017 Received: August 3, 2017
Dear Punitha Samy:
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.
Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.
{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 (reporting of medical devicerelated 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), please contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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,
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Acting 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
510(k) Number (if known)
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 15.0 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 30.1minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ---------------------------------------------- |
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K171104
Device Name
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue
Indications for Use (Describe)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Tested Chemotherapy Drug And Concentration | Average Breakthrough Detection Time |
|---|---|
| Carboplatin, 10 mg/ml | > 240 minutes |
| Carmustine (3.3 mg/ml) | 2.4 minutes |
| Cisplatin (BCNU), 1.0 mg/ml | > 240 minutes |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | > 240 minutes |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 minutes |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 minutes |
| Etoposide (Toposar), 20.0 mg/ml | > 240 minutes |
| Fluorouracil, 50.0 mg/ml | > 240 minutes |
| Ifosfamide , 50.0 mg/ml | > 240 minutes |
| Methotrexate, 25 mg/ml | > 240 minutes |
| Mitomycin C, 0.5 mg/ml | > 240 minutes |
| Mitoxantrone, 2 mg/ml | > 240 minutes |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 minutes |
| ThioTEPA (10.0 mg/ml) | 1.9 minutes |
| Vincristine Sulfate, 1.0 mg/ml | > 240 minutes |
The following chemotherapy drugs and concentration have extremely low permeation time. Carmustine (3.3 mg/ml): 2.4 minutes ThioTEPA (10.0 mg/ml): 1.9 minutes
Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{4}------------------------------------------------
K171104
510 (K) SUMMARY
| 1.0 | 510 (K) SUMMARY | |
|---|---|---|
| 2.0 | Submitter | YTY INDUSTRY (MANJUNG) SDN. BHD.,Lot 1422-1424, Batu 10 Lekir32020 Sitiawan, PerakMalaysia |
| Tel | 605-6908533 | |
| Fax | 605-6908533 | |
| Name of Contact Person | Punitha Samy (Ms)E-mail: punitha.samy@ytygroup.com.my | |
| Date Summary Prepared | August 24, 2017 | |
| 3.0 | Name of Device | |
| Trade Name: | Non-Sterile, Powder Free Nitrile Examination Gloves Tested For UseWith Chemotherapy Drugs - BlueNon-Sterile, Powder Free Nitrile Examination Gloves Tested For UseWith Chemotherapy Drugs - Cobalt Blue | |
| Common Name: | Nitrile Examination Gloves | |
| Classification Name: | Patient Examination Gloves, Powder Free | |
| Device Classification: | I | |
| Regulation No. & Classification Name: Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC)Patient Examination Gloves (21 CFR 880.6250 product code LZA) | ||
| Panel: | General Hospital |
4.0 Identification of The Legally Marketed Devices that equivalency is claimed:
| Device Name | Brightway Brand Nitrile ExaminationGloves, Powder Free, [Sterling/Grey] Tested ForUse WithChemotherapy Drugs |
|---|---|
| Predicate 510(K)number: | K161215 |
| Device Classification: | I |
| Product Code: | LZC |
{5}------------------------------------------------
5.0 Description of The Device
Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use of Glove
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.
| Characteristic | Concentration | BlueAverage Breakthrough Detection Time (minutes) | Cobalt BlueAverage Breakthrough Detection Time (minutes) |
|---|---|---|---|
| Carboplatin | 10mg/ml | > 240 | > 240 |
| *Carmustine | 3.3mg/ml | 15.0 | 2.4 |
| Cisplatin (BCNU) | 1.0mg/ml | > 240 | > 240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 | > 240 |
| Methotrexate | 25mg/ml | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 |
| Thiotepa | 10.0mg/ml | 30.1 | 1.9 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 |
| Warning Statement | *WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 15.0 minutes and ThioTepa: 30.1 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA | * WARNING: Please note that the following drugs have extremely low permeation times: Carmustine: 2.4 minutes and ThioTepa: 1.9 minutes. NOT TO BE USED WITH CARMUSTINE OR THIOTEPA |
{6}------------------------------------------------
7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for substantial equivalent discussion
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs – Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue have the below technological characteristic compared to ASTM or Equivalent standards.
This glove is compliant with the ASTM standards and similar to the predicate device in the market, which has a glove thickness less than 0.10mm and length less than 270mm. The chemotherapy claim is similar to Predicate.
| Characteristic | Standards | Device Performance | |||
|---|---|---|---|---|---|
| Predicate | Blue | Cobalt Blue | |||
| 510(K) Number | K161215 | K171104 | K171104 | ||
| Dimension | ASTM D6319-10 | Min 240mm | Min 240mm | Min 240mm | |
| Physical Properties | ASTM D6319-10 | Meets | Meets | Meets | |
| Thickness | Finger | ASTM D6319-10 | 0.03 – 0.05mm | 0.03mm min | 0.03mm min |
| Palm | 1.5 – 0.08mm | 0.05mm min | 0.05mm min | ||
| Cuff | 1.6 – 0.09mm | 0.05mm min | 0.05mm min | ||
| Powder-free | ASTM D6124-06(<2mg/glove) | Meets | Meets | Meets | |
| Bio-compatibility | Primary skinirritationISO 10993-10(2010) | Not a primaryskin irritantunder theconditions ofthe study | Under thecondition of thestudy the deviceis non-irritant | Under thecondition of thestudy the device isnon-irritant | |
| DermalSensitizationISO 10993-10(2010) | Not a contactsensitizer underthe conditionsof the study | Under thecondition of thestudy the deviceis non-sensitizer | Under thecondition of thestudy the device isnon-sensitizer |
Page 3 of 7
{7}------------------------------------------------
| Table 2 | |||||
|---|---|---|---|---|---|
| Characteristic | Testedaccording toASTM D6978-05 | Device Performance | |||
| Concentration | Predicate- K161215 | Blue | Cobalt Blue | ||
| Predicate | Current | Current | |||
| Carboplatin | 10mg/ml | - | > 240 | > 240 | |
| *Carmustine | 3.3mg/ml | 10.1 | 15.0 | 2.4 | |
| Cisplatin | 1.0mg/ml | > 240 | > 240 | > 240 | |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | > 240 | > 240 | > 240 | |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | > 240 | > 240 | |
| DoxorubicinHydrochloride | 2.0mg/ml | > 240 | > 240 | > 240 | |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 | > 240 | |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 | > 240 | |
| Ifosfamide (Ifex) | 50.0mg/ml | > 240 | > 240 | > 240 | |
| Methotrexate | 25mg/ml | - | > 240 | > 240 | |
| Mitomycin C | 0.5mg/ml | - | > 240 | > 240 | |
| Mitoxantrone | 2 mg/ml | > 240 | > 240 | > 240 | |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 | > 240 | |
| Thiotepa | 10.0mg/ml | 30.2 | 30.1 | 1.9 | |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 | > 240 | |
| Warning Statement | *WARNING: DoNot Use withCarmustine andThiotepa.Carmustineand Thiotepahas extremelylowpermeationtime of lessthan 30minutesrespectively | *WARNING:Please note thatthe followingdrugs haveextremely lowpermeationtimes:Carmustine:15.0 minutesand ThioTepa:30.1 minutes.NOT TO BEUSED WITHCARMUSTINEOR THIOTΕΡΑ | * WARNING: Pleasenote that the followingdrugs have extremelylow permeation times:Carmustine: 1.82minutes and ThioTepa:0.93 minutes. NOTTO BE USED WITHCARMUSTINE ORTHIOTEPA |
Таыь 2
{8}------------------------------------------------
| Characteristics | ||||
|---|---|---|---|---|
| PredicateK161215 | Subject DeviceBlue | Subject DeviceCobalt Blue | Comparison | |
| Water tightness(1000ml) | Passes | Passes | Passes | Same |
| Color | Sterling/Grey | Blue | Cobalt Blue | Different |
| Material | Nitrile | Nitrile | Nitrile | Same |
| Size | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Extra SmallSmallMediumLargeExtra Large | Same |
| Texture | Finger Textured | Finger Textured | FingerTextured | Same |
| Single Use | Single Use | Single Use | Single Use | Same |
| Expiration claim | No Expiration Date Claimed | 5 years | 5 years | Different |
| Bio-compatibility | PassesNot primary skin irritant under theconditions of the study. | PassesUnder the condition of the study thedevice is non-irritant | PassesUnder the condition of the studythe device is non-irritant | Same |
| PassesNot a contact sensitizer under theconditions of the study. | PassesUnder the condition of the study thedevice in non-sensitizer | PassesUnder the condition of thestudy the device in non-sensitizer | Same |
Table 3
Page 5 of 7
{9}------------------------------------------------
| Indications for Use | |||
|---|---|---|---|
| A patient Examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. | Same | |
| Tested Chemotherapy Drug And Concentration | Average Break through Detection Time | Similar | |
| Carmustine (3.3 mg/ml)Cisplatin (BCNU), 1.0 mg/mlCyclophosphamide (Cytoxan), 20.0 mg/mlDacarbazine (DTIC), 10.0 mg/mlDoxorubicin Hydrochloride, 2.0 mg/mlEtoposide (Toposar), 20.0 mg/mlFluorouracil, 50.0 mg/mlIfosfamide , 50.0 mg/mlMethotrexate, 25 mg/mlMitomycin C, 0.5 mg/mlMitoxantrone, 2 mg/mlPaclitaxel (Taxol), 6.0 mg/mlThioTEPA (10.0 mg/ml)Vincristine Sulfate, 1.0 mg/ml | 5.4 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min->240 min>240 min>240 min40.4 min>240 min | ||
| Carboplatin, 10 mg/mlCarmustine (3.3 mg/ml)Cisplatin (BCNU), 1.0 mg/mlCyclophosphamide (Cytoxan), 20.0 mg/mlDacarbazine (DTIC), 10.0 mg/mlDoxorubicin Hydrochloride, 2.0 mg/mlEtoposide (Toposar), 20.0 mg/mlFluorouraci1, 50.0 mg/mlIfosfamide , 50.0 mg/mlMethotrexate, 25 mg/mlMitomycin C, 0.5 mg/mlMitoxantrone, 2 mg/mlPaclitaxel (Taxol), 6.0 mg/mlThioTEPA (10.0 mg/ml)Vincristine Sulfate, 1.0 mg/ml | |||
| >240 min15.0 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min30.1 min>240 min | |||
| Carboplatin, 10mg/mlCarmustine (3.3 mg/ml)Cisplatin (BCNU), 1.0 mg/mlCyclophosphamide (Cytoxan), 20.0 mg/mlDacarbazine (DTIC), 10.0 mg/mlDoxorubicin Hydrochloride, 2.0 mg/mlEtoposide (Toposar), 20.0 mg/mlFluorouracil, 50.0 mg/mlIfosfamide , 50.0 mg/mlMethotrexate, 25 mg/mlMitomycin C, 0.5 mg/mlMitoxantrone, 2 mg/mlPaclitaxel (Taxol), 6.0 mg/mlThioTEPA (10.0 mg/ml)Vincristine Sulfate, 1.0 mg/ml | |||
| >240 min2.4 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min>240 min1.9 min>240 min | |||
| Tested for use with Chemotherapy Drugs.Carmustine has extremely low permeation time of less than 30 minutes | The following chemotherapy drugs and concentration have extremely low permeation time.Carmustine (3.3 mg/ml): 15.0 min ThioTEPA (10.0 mg/ml): 30.1 min | Same | |
| The following chemotherapy drugs and concentration have extremely low permeation time.Carmustine (3.3 mg/ml): 2.4 minThioTEPA (10.0 mg/ml): 1.9 min |
{10}------------------------------------------------
8.0 Conclusion
The subject devices are as safe, as effective, and perform as well or better than the legally marketed predicate device K161215 (Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs).
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§ 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.