Who can help prepare an FDA 510(k) submission like Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Q: Who is the manufacturer of Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

Riverstone Resources Sdn Bhd filed the 510(k) submission for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (K190725).

Q: What is the FDA product code for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

LZA. It is classified under 21 CFR 880.6250 as a Class 1 device in the General Hospital panel.

Q: What is the regulatory pathway for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

510(k) clearance (submission type: Traditional).

K190725 · Riverstone Resources Sdn Bhd · LZA · Dec 17, 2019 · General Hospital

Device Facts

Record ID	K190725
Device Name	Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
Applicant	Riverstone Resources Sdn Bhd
Product Code	LZA · General Hospital
Decision Date	Dec 17, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6250
Device Class	Class 1

Intended Use

The Nitrile 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. 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.

Device Story

Disposable nitrile latex examination glove; sterile; powder-free; white. Worn by clinicians on hands/fingers to prevent cross-contamination during patient examinations. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Provides barrier protection; breakthrough times for various chemotherapy agents documented. Used in clinical settings; no specialized operation required.

Clinical Evidence

Bench testing only. No clinical data. Device performance verified against ASTM D6319-10 (dimensions, physical properties, pinholes), ASTM D5151-06 (residual powder), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility confirmed via ISO 10993-10 (primary skin irritation, dermal sensitization) and ISO 10993-11 (acute systemic toxicity).

Technological Characteristics

Nitrile synthetic latex; powder-free; sterile. Dimensions: 230mm length, 0.05mm minimum palm/finger thickness. Complies with ASTM D6319-10. Sterilization via ISO 11737-2/EN ISO 11137-2. Biocompatibility per ISO 10993-5, 10993-10, 10993-11.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

Regulatory Classification

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.

Predicate Devices

White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim (K180452)

Related Devices

K180452 — White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim · Riverstone Resources Sdn Bhd · Jun 12, 2018
K170290 — Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr · Shen Wei USA, Inc. · May 24, 2017
K191753 — Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) · Medline Industries, Inc. · Mar 17, 2020
K160560 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) · Hartalega Sdn Bhd · Aug 4, 2016
K171782 — Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs · Blue Sail Medical Co.,Ltd · Oct 12, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 17, 2019 Riverstone Resources SDN BHD Suresh Kumar QA Manager Lot 56, No 15, Jalan Jasmin 2 Bukit Beruntung, 48300 My Re: K190725 Trade/Device Name: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: November 14, 2019 Received: November 18, 2019 Dear Suresh 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. 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 (OS) 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. For Elizabeth Claverie, M.S. Assistant Director for THT4B2 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) K190725 #### Device Name Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White. #### Indications for Use (Describe) The Nitrile 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. 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. Chemotherapy Drug and Concentration Minimum Breakthrough detection time in Minutes - 1) Carmustine (BCNU)(3.3mg/ml) 39 minutes 2) Cyclophosphamide (20mg/ml) > 240 minutes 3) Cisplatin (1.0mg/ml) > 240 minutes 4) Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes > 240 minutes 5) Etoposide (20mg/ml) 6) Fluorouracil (50mg/ml) > 240 minutes 7) Methorexate (25mg/ml) > 240 minutes > 240 minutes 8) Paclitaxel (6mg/ml) 9) Thiotepa (10mg/ml) 97.6 minutes #### Caution: Thiotepa (10mg/ml),Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml),Breakthrough Detected at 39 Minutes 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." {3}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor ### 510k No:K190725 #### 510(K) Summary Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs claim,White #### 1.0 Submitter : | Company Name | : RIVERSTONE RESOURCES SDN BHD | |-----------------|--------------------------------------------------------------------------------------------------------------------------| | Company Address | : Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung 48300,Bukit Beruntung Selangor Malaysia. | | Contact Person | : Mr Suresh Kumar | | Telephone No | : 603-60283033 | | Email | : qa1@riverstone.com.my | ## 2.0 Preparation Date : 11th December 2019 ### 3.0 Name of the Device Trade Name / Proprietary Name: Nitrile Examination Glove Sterile tested for use with Chemotherapy Drugs claims,White Device Name: Nitrile Patient Examination gloves. Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA and LZC. {4}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor ### 510k No:K190725 #### 4.0) Identification of The Legally Marketed Device: K180452, White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim #### 5.0 Device Description The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05. #### 6.0 Indications for Use The Nitrile 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. 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. | Chemotherapy Drug and concentration | Minimum Breakthrough detection time | |---------------------------------------|-------------------------------------| | | in Minutes | | 1)Carmustine (BCNU) (3.3mg/ml) | 39 minutes | | 2)Cyclophosphamide (20mg/ml) | > 240 minutes | | 3)Cytarabine (10mg/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) | 97.6 minutes | Caution: Thiotepa (10mg/ml), Breakthrough Detected at 97.6 Minutes Carmustine (3.3mg/ml), Breakthrough Detected at 39 Minutes {5}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor #### 510k No:K190725 #### 7.0 Specification for Nitrile gloves: 7.1 Dimension and Thickness of Gloves | Dimension | Size S | Size M | Size L | Size XL | |---------------------------------------|--------|--------|--------|---------| | Overall Length (mm) (Minimum) | 230 | 230 | 230 | 230 | | Width (± 5mm) | 85 | 95 | 105 | 115 | | Thickness at Palm (mm) (Minimum) | 0.05 | 0.05 | 0.05 | 0.05 | | Thickness at Finger Tip (mm)(Minimum) | 0.05 | 0.05 | 0.05 | 0.05 | ### 7.2 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 #### 7.3 Summary of the Technological Characteristics of the Device compared to the Predicate Device | Characteristics | Acceptance Criteria | Nitrile Examination Glove Sterile tested for use with chemotherapy drugs claim, White K190725 | White Nitrile Examination Gloves Sterile Tested For Used With Chemotherapy Drugs Claim, K180452 | Comparison | |-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | LZA and LZC | LZA and LZC | LZA and LZC | Same | | | | | 510k No:K190725 | | | 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. | Same | | Description | | Sterile Examination glove made of Nitrile and color White and tested with chemotherapy Drugs | Sterile Examination glove made of Nitrile and color White | Same | | Presentation | | Sterile gloves are provided in Pouches | Sterile gloves are provided in Pouches | Same | | Ambidextrous | | Yes | Yes | Same | | Material use | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Nitrile Synthetic Latex | Same | | Colour | | White | White | Same | | Sterility | Sterility ISO 11737- 2:2009 EN ISO 11137- 2:2015 | Sterility | Sterility | Same | | Single used | | Single used | Single used | Same | | Non Sterile or Sterile | | Sterile | Sterile | Same | | | 510k No:K190725 | | | | | Dimensions | Overall Length (mm) Min 230 mm Width (± 5mm) Size S = 85mm Size M = 95mm Size L = 105mm Size XL = 115mm Thickness at Palm (mm) Min; 0.05 mm Thickness at Finger Tip (mm) Min 0.05 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Same | | 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 | Same | | Freedom from pinholes | AQL 2.5 Inspection Level G-1 ASTM D6319-10 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Same | | Residual Powder | < 2.0 mg/pc ASTM D6124-06 | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Same | | Biological Evaluation on Medical Device -Primary Skin Irritation Test | Non irritant- Primary Skin Irritation in Rabbit | 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. | Same | | Biological Evaluation on Medical Device- Dermal Sensitization Assay | Non -sensitizer- Skin sensitization in Giunea pigs ISO 10993-10 | 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. 510k No:K190725 | Same | | Acute Systemic Toxicity | ISO 10993-11 | Under the condition of this study, Nitrile Examination glove, sterile shows no adverse biological reaction | Under the condition of this study, Nitrile Examination glove, sterile shows no adverse biological reaction | same | | Resistance against Chemotherapy Drugs | Standards Practice for Assessment of resistance of Medical Glove to Permeation by Chemotherapy drugs ASTM D6978-05(2013) | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time : 39 µg/cm²/minute 2) Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 3) Cisplatin (1.0mg/ml or 1,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 4)Doxorubicin Hydrochloride (2.0mg/l), Minimum Breakthrough detection time: >240 µg/cm²/minute 5) Etoposide | 1) Carmustine (3.3mg/ml or 3000ppm), Minimum Breakthrough detection time : 17.1 µg/cm²/minute 2) Cyclophosphamide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 3) Cisplatin (1.0mg/ml or 1,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Minimum | Similar | | | (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 6) Flourouracil (50mg/ml or 50,000), Minimum Breakthrough detection time: >240 µg/cm²/minute 7) Paclitaxel (6mg/ml or 6,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 8) Thiotepa (10mg/ml or 10,000ppm), Minimum Breakthrough detection time: 97.6 µg/cm²/minute 9) Methotrexate (25 mg/ml ), Minimum Breakthrough detection time: >240 µg/cm²/minute | Breakthrough detection time: >240 µg/cm²/minute 5) Etoposide (20mg/ml or 20,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 6) Flourouracil (50mg/ml or 50,000), Minimum Breakthrough detection time: >240 µg/cm²/minute 7) Paclitaxel (6mg/ml or 6,000ppm), Minimum Breakthrough detection time: >240 µg/cm²/minute 8) Thiotepa (10mg/ml or 10,000ppm), Minimum Breakthrough detection time: 56.9 µg/cm²/minute 9) Dacarbazine (1.0 mg/ml ), Minimum Breakthrough detection time: >240 µg/cm²/minute | | | {6}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor ### 510k No:K190725 {7}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor {8}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor #### 510k No:K190725 {9}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor 510k No:K190725 {10}------------------------------------------------ Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung. Selangor ### 510k No:K190725 ### 8.0 Summary of Non-Clinical Testing. Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below: | Technological Characteristics | Standard/Test/FDA Guidance | Result Summary | |-----------------------------------------------------------------------------|----------------------------|----------------| | Dimensions | ASTM D6319-10 | Meets | | Physical properties | ASTM D6319-10 | Meets | | Freedom from pinholes | ASTM D6319-10 | Meets | | Residual Powder | ASTM D5151-06 | Meets | | Biological Evaluation on Medical Device -Primary Skin Irritation Test | ISO 10993-10 | Meets | | Biological Evaluation on Medical Device- Dermal Sensitization Assay | ISO 10993-10 | Meets | | Acute Systemic Toxicity | ISO 10993-11 | Meets | The subject device meets the applicable requirements for patients gloves with regards to dimension and sizes, physical properties, freedom from holes and powder Residuals as found in the following standards: ASTM D6139, ASTM D5151, ASTM D6124.The subject device passes biological reactivity testing for dermal sensitization, irritation and acute systemic toxicity with accordance ISO10993-10 AND ISO 10993-11 ### 9.0 Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!